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Brazilian Health Surveillance Agency (ANVISA)

www.anvisa.gov.br

Public Consultation No 47 of 25 August 2008.

D.O.U. (Official State Gazette) of 26.8.2008 The Board of the National Health Surveillance Agency, in the exercise of the powers granted by Item IV of Article 11 and Article 35 of ANVISA’s Regulations, approved by Decree No. 3029 of 16 April 1999, and having regard to the provisions of Item V and points 1 and 3 of Article 54 of the Internal Regulations approved in accordance with Appendix I of ANVISA Administrative Ruling No. 354 of 11 August 2006, republished in the DOU of 21 August 2006, at a meeting held on 19 August 2008,

Article 1 - A period of 30 (thirty) days from the date of publication of this Public Consultation is hereby declared open for presenting criticism and suggestions concerning the proposed Regulatory Instruction laying down specific criteria for grouping ORTHOPAEDIC IMPLANTS into families and systems for registers, in the Annex.

Art. 2. The full text of the proposed Regulatory Instruction referred to in the previous Article will be available, during the consultation period, at the following website http://www.anvisa.gov.br, and suggestions should be sent in writing to the following address: Agência Nacional de Vigilância Sanitária, Gerência-Geral de Tecnologia de Produtos para Saúde, SEPN 515, Bloco B, Ed. Ômega, Asa Norte, Brasília, DF, CEP 70.770-502, Brazil, or Fax: (061)3448-1058 or e-mail: [email protected] with the subject entered as “Requisitos Específicos para agrupamento em famílias e sistemas de IMPLANTES ORTOPÉDICOS para fins de registro” (Specific criteria for grouping ORTHOPAEDIC IMPLANTS into families and systems for registers).

Art. 3. At the end of the period specified in Art. 1, the National Health Surveillance Agency will talk to the Bodies and Entities involved and other parties with an interest in the matter, and ask them to nominate representatives for subsequent discussions, in order to arrive at a final wording.

DIRCEU RAPOSO DE MELLO

http://www.anvisa.gov.br/

mailto:[email protected]

REGULATORY INSTRUCTION No

laying down specific criteria for grouping ORTHOPAEDIC IMPLANTS into families and systems for registers.

The Director-President of the National Health Surveillance Agency, in the exercise of the powers granted by the Presidential Decree of 4 January 2008 appointing him and Item X of Article 13 of ANVISA’s Regulations, approved by Decree No 3029 of 16 April 1999, and having regard to the provisions of Item VIII of Article 16 and Item II, paragraph 2 of Article 55 of the Internal Regulations approved in accordance with Appendix I of ANVISA Administrative Ruling No 354 of 11 August 2006, republished in the DOU of 21 August 2006,

Whereas the sole paragraph of Article 1 of Resolution of the Board No 59 of 25 August 2008, established the technical regulation containing the general requirements for grouping orthopaedic implants into families and systems for registers;

Whereas there is a need to establish specific criteria to guide the preparation of procedures for registering products classified as orthopaedic implants with the aim of enabling risk convergence for such products, resolves:

Article 1 The specific criteria for grouping orthopaedic implants into families and systems for registers contained in the Annex to this Regulatory Instruction are approved.

Article 2 All criteria applicable to replacement implants for hip, knee, shoulder, elbow, ankle, wrist and temporomandibular joints.

Article 3 All criteria applicable to implants for osteosynthesis: plates, screws, clips, flexible wires and flexible cables, pins and rigid wires, intramedullary nails, anchors for attaching soft tissue to bone, graft bearing diaphyseal spacers, implantable mandibular braces, calvarial fixation devices, halo braces and spinal implants have been taken into consideration.

Article 4 This Regulation shall enter into force on the date of its publication.

DIRCEU RAPOSO DE MELLO

ANNEX I

SPECIFIC CRITERIA FOR GROUPING JOINT REPLACEMENT IMPLANTS INTO FAMILIES AND SYSTEMS FOR REGISTERS

PART 1 – HIP JOINT

1.1 The following criteria apply to specific parts for grouping hip joint replacements into families and systems for registers:

CRITERIA COMPONENTS

Material All components.

Composition (monolithic/composite) Acetabulum

Method of fixation (cemented/cementless) - Pin - Acetabulum

Modularity - Head/pin - Acetabular nucleus/capsule

Functionality (with or without compensation for loss of extrinsic stabilisation of the joint)*

Acetabular nucleus

Range of intracomponent motion – centrality of joint (monopolar/bipolar)*

Femur head

*Specific criteria.

1.2 In addition to the criteria specified in the previous item, the following specific criteria apply to hip joint replacement systems:

SPECIFICATION CRITERIA APPLICABLE TO THE SYSTEM

Scope of implant – with or without acetabular arthroplasty.

- Partial - Total

Extent of interference with the epiphysis - Full - Surface

Extent of compartmentalisation of the system Unicompartmental only

Joint containment structure Anatomical only

1.3 Implants with resurfacing treatments aggregating raw materials which differ from those of their production are to be grouped in a different register from implants without resurfacing treatment of this kind.

1.4 Composite acetabular nuclei containing various materials (metals, polymers, ceramics and polymer-ceramics) need to be classed in different registers.

1.5 Description of possible hip joint replacement systems:

a) Total arthroplasty

a.1) Non-modular systems for total arthroplasties – cemented:

a.1.1 Non-modular systems for total arthroplasties – cemented, with monolithic acetabulum:

a.1.2 Non-modular systems for total arthroplasties – cemented, with composite acetabulum:

a.2) Modular systems for total arthroplasties:

a.2.1 Modular systems for total arthroplasties with a modular, cemented pin, ceramic head with monolithic acetabulum:

a.2.2 Modular systems for total arthroplasties with a modular, cemented pin, ceramic head, composite acetabulum and cemented capsule;

a.2.3 Modular systems for total arthroplasties with a modular, cemented pin, ceramic head, composite acetabulum and cementless capsule;

a.2.4 Modular systems for total arthroplasties with a modular, cemented pin, metallic head with monolithic acetabulum:

a.2.5 Modular systems for total arthroplasties with a modular, cemented pin, metallic head, composite acetabulum and cemented capsule;

a.2.6 Modular systems for total arthroplasties with a modular, cemented pin, metallic head, composite acetabulum and cementless capsule;

a.2.7 Modular systems for total arthroplasties with a modular, cementless pin, ceramic head with monolithic acetabulum:

a.2.8 Modular systems for total arthroplasties with a modular, cementless pin, ceramic head, composite acetabulum and cemented capsule;

a.2.9 Modular systems for total arthroplasties with a modular, cementless pin, ceramic head, composite acetabulum and cementless capsule;

a.2.10 Modular systems for total arthroplasties with a modular, cementless pin, metallic head with monolithic acetabulum:

a.2.11 Modular systems for total arthroplasties with a modular, cementless pin, metallic head, composite acetabulum and cemented capsule;

a.2.12 Modular systems for total arthroplasties with a modular, cementless pin, metallic head, composite acetabulum and cementless capsule;

b) Partial arthroplasty

b.1) Non-modular partial arthroplasty

b.1.1 – Thompson arthroplasty – cemented.

b.2) Modular, cemented partial arthroplasty systems

b.2.1 – modular metal pin, metallic head.

b.2.2 – modular metal pin, ceramic head.

b.3) Modular, cemented bipolar partial arthroplasty systems

b.3.1 – modular metal pin, metal head and bipolar component.

b.3.2 – modular metal pin, ceramic head and bipolar component.

b.3.2 – non-modular metal pin and bipolar component. (modularity ensured by a bipolar component)

c) Resurfacing arthroplasty

c.1) Systems for resurfacing total arthroplasties:

c.1.1 – System for resurfacing the femur with a cemented acetabulum.

c.1.2 – System for resurfacing the femur with a cementless acetabulum.

1.6 Description of possible families of hip joint replacement components:

d) Total arthroplasty

d.1 Family of non-modular pins

d.2 Family of modular pins – cemented

d.3 Family of modular pins – cementless

d.4 Head family – ceramic

d.5 Head family – metallic

d.6 Family of bipolar adaptation mechanism

d.7 Family of monolithic polymer acetabula, cemented

d.8 Family of ceramic acetabular nuclei (cementless)

d.9 Family of metallic acetabular nuclei (cementless)

d.10 Family of unrestricted polymer acetabular nuclei (cementless)

d.11 Family of partially restricted polymer acetabular nuclei (cementless)

d.12 Family of polymer acetabular nuclei with metallic joint surface (cementless)

d.13 Family of polymer acetabular nuclei with ceramic joint surface (cementless)

d.14 Family of acetabular capsules, cemented (metal)

d.15 Family of acetabular capsules, cementless (metal)

e) Resurfacing arthroplasty

e.1 Head family (consider the general criterion – material).

e.2 Family of monolithic metal acetabula, cemented.

e.3 Family of monolithic metal acetabula, cementless.

1.7 Description of possible accessories for families of implantable hip joint replacement components and systems:

1.7.1 Acetabulum accessories (where applicable to the product): screws, wedges, meshes and acetabular reinforcements.

PART 2 – KNEE JOINT

2.1 The following criteria apply to specific parts for grouping knee joint replacements into families and systems for registers:

1.7.2 Pin accessories (where applicable to the product): centralisers, cement restrictors, wedges and meshes.

CRITERIA COMPONENTS

Material All components

Composition (monolithic/composite) Tibial component

Method of fixation (cemented/cementless) - Femoral component - Tibial component

Modularity Tibial component

Range of motion (fixed or mobile)* Tibia platform

* Specific criterion.

2.2 In addition to the criteria specified in the previous item, the following specific criteria apply to knee joint replacement systems:

CRITERIA APPLICABLE TO THE SYSTEM SPECIFICATION

Functionality (structural restrictions) - Restricted - Partially restricted - Unrestricted

Scope of implant - Partial - Total

Extent of interference with the epiphysis Surface only

Extent of compartmentalisation of the system - Femoropatellar - Femorotibial - Multicompartmental

Joint containment structure Anatomical only

2.3 Description of possible knee joint replacement systems:

a) Femorotibial unicompartmental total arthroplasty:

a.1 Femorotibial unicompartmental total arthroplasty system with metal femoral component, fixed bearing and cemented tibia platform;

a.2 Femorotibial unicompartmental total arthroplasty system with metal femoral component, fixed bearing and cementless tibia platform;

a.3 Femorotibial unicompartmental total arthroplasty system with metal femoral component, mobile bearing and cemented tibia platform;

a.4 Femorotibial unicompartmental total arthroplasty system with metal femoral component, mobile bearing and cementless tibia platform;

a.5 Femorotibial unicompartmental total arthroplasty system with ceramic femoral component, fixed bearing and cemented tibia platform;

a.6 Femorotibial unicompartmental total arthroplasty system with ceramic femoral component, fixed bearing and cementless tibia platform;

a.7 Femorotibial unicompartmental total arthroplasty system with ceramic femoral component, mobile bearing and cemented tibia platform;

a.8 Femorotibial unicompartmental total arthroplasty system with ceramic femoral component, mobile bearing and cementless tibia platform;

b) Femoropatellar unicompartmental total arthroplasty:

b.1 Femoropatellar unicompartmental total arthroplasty system with metal femoral component, and cemented, monolithic patellar component;

b.2 Femoropatellar unicompartmental total arthroplasty system with metal femoral component, and cemented, composite patellar component;

b.3 Femoropatellar unicompartmental total arthroplasty system with metal femoral component, and cementless, monolithic patellar component;

b.4 Femoropatellar unicompartmental total arthroplasty system with metal femoral component, and cementless, composite patellar component;

b.5 Femoropatellar unicompartmental total arthroplasty system with ceramic femoral component, and cemented, monolithic patellar component;

b.6 Femoropatellar unicompartmental total arthroplasty system with ceramic femoral component, and cemented, composite patellar component;

b.7 Femoropatellar unicompartmental total arthroplasty system with ceramic femoral component, and cementless, monolithic patellar component;

b.8 Femoropatellar unicompartmental total arthroplasty system with ceramic femoral component, and cementless, composite patellar component;

c) Total multicompartmental arthroplasty

c.1 Total multicompartmental arthroplasty with metal femoral component and non-modular tibial component:

c.1.1 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, monolithic tibial component and cemented monolithic patellar component;

c.1.2 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, monolithic tibial component and cemented composite patellar component;

c.1.3 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, monolithic tibial component and cementless composite patellar component;

c.1.4 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, composite tibial component and cemented monolithic patellar component;

c.1.5 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, composite tibial component and cemented composite patellar component;

c.1.6 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, composite tibial component and cementless composite patellar component;

c.1.7 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, monolithic tibial component and cemented monolithic patellar component;

c.1.8 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, monolithic tibial component and cemented composite patellar component;

c.1.9 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, monolithic tibial component and cementless composite patellar component;

c.1.10 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, composite tibial component and cemented monolithic patellar component;

c.1.11 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, composite tibial component and cemented composite patellar component;

c.1.12 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, composite tibial component and cementless composite patellar component;

c.1.13 Multicompartmental total arthroplasty system, restricted, with cementless femoral component, monolithic tibial component and cemented monolithic patellar component;

c.1.14 Multicompartmental total arthroplasty system, restricted, with cementless femoral component, monolithic tibial component and cemented composite patellar component;

c.1.15 Multicompartmental total arthroplasty system, restricted, with cementless femoral component, monolithic tibial component and cementless composite patellar component;

c.1.16 Multicompartmental total arthroplasty system, restricted, with cementless femoral component, composite tibial component and cemented monolithic patellar component;

c.1.17 Multicompartmental total arthroplasty system, restricted, with cementless femoral component, composite tibial component and cemented composite patellar component;

c.1.18 Multicompartmental total arthroplasty system, restricted, with cementless femoral component, composite tibial component and cementless composite patellar component;

c.1.19 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, monolithic tibial component and cemented monolithic patellar component;

c.1.20 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, monolithic tibial component and cemented composite patellar component;

c.1.21 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, monolithic tibial component and cementless composite patellar component;

c.1.22 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, composite tibial component and cemented monolithic patellar component;

c.1.23 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, composite tibial component and cemented composite patellar component;

c.1.24 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, composite tibial component and cementless composite patellar component;

c.2 Total multicompartmental arthroplasty with ceramic femoral component and non-modular tibial component:

c.2.1 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, monolithic tibial component and cemented monolithic patellar component;



c.2.4 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, composite tibial component and cemented monolithic patellar component;

c.2.5 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, composite tibial component and cemented composite patellar component;

c.2.6 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, composite tibial component and cementless composite patellar component;

c.3 Multicompartmental total arthroplasty with metal femoral component, modular tibial component (tibia platform and bearing) and taking into consideration only cemented monolithic patellar components:

c.3.1 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, fixed bearing, cemented tibia platform and cemented monolithic patellar component;

c.3.2 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, fixed bearing, cemented tibia platform and cemented composite patellar component;

c.3.3 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, fixed bearing, cemented tibia platform and cementless composite patellar component;

c.3.4 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, fixed bearing, cementless tibia platform and cemented monolithic patellar component;

c.3.5 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, fixed bearing, cementless tibia platform and cemented composite patellar component;

c.3.6 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, fixed bearing, cementless tibia platform and cementless composite patellar component;

c.3.7 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, fixed bearing, cemented tibia platform and cemented monolithic patellar component;

c.3.8 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, fixed bearing, cemented tibia platform and cemented composite patellar component;

c.3.9 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, fixed bearing, cemented tibia platform and cementless composite patellar component;

c.3.10 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, fixed bearing, cementless tibia platform and cemented monolithic patellar component;

c.3.11 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, fixed bearing, cementless tibia platform and cemented composite patellar component;

c.3.12 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, fixed bearing, cementless tibia platform and cementless composite patellar component;

c.3.13 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, mobile bearing, cemented tibia platform and cemented monolithic patellar component;

c.3.14 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, mobile bearing, cemented tibia platform and cemented composite patellar component;

c.3.15 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, mobile bearing, cemented tibia platform and cementless composite patellar component;

c.3.16 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, mobile bearing, cementless tibia platform and cemented monolithic patellar component;

c.3.17 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, mobile bearing, cementless tibia platform and cemented composite patellar component;

c.3.18 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, mobile bearing, cementless tibia platform and cementless composite patellar component;

c.3.19 Multicompartmental total arthroplasty system, restricted, with cementless femoral component, fixed bearing, cemented tibia platform and cemented monolithic patellar component;

c.3.20 Multicompartmental total arthroplasty system, restricted, with cementless femoral component, fixed bearing, cemented tibia platform and cemented composite patellar component;

c.3.21 Multicompartmental total arthroplasty system, restricted, with cementless femoral component, fixed bearing, cemented tibia platform and cementless composite patellar component;

c.3.22 Multicompartmental total arthroplasty system, restricted, with cementless femoral component, fixed bearing, cementless tibia platform and cemented monolithic patellar component;

c.3.23 Multicompartmental total arthroplasty system, restricted, with cementless femoral component, fixed bearing, cementless tibia platform and cemented composite patellar component;

c.3.24 Multicompartmental total arthroplasty system, restricted, with cementless femoral component, fixed bearing, cementless tibia platform and cementless composite patellar component;

c.3.25 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, fixed bearing, cemented tibia platform and cemented monolithic patellar component;

c.3.26 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, fixed bearing, cemented tibia platform and cemented composite patellar component;

c.3.27 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, fixed bearing, cemented tibia platform and cementless composite patellar component;

c.3.28 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, fixed bearing, cementless tibia platform and cemented monolithic patellar component;

c.3.29 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, fixed bearing, cementless tibia platform and cemented composite patellar component;

c.3.30 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, fixed bearing, cementless tibia platform and cementless composite patellar component;

c.3.31 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, mobile bearing, cemented tibia platform and cemented monolithic patellar component;

c.3.32 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, mobile bearing, cemented tibia platform and cemented composite patellar component;

c.3.33 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, mobile bearing, cemented tibia platform and cementless composite patellar component;

c.3.34 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, mobile bearing, cementless tibia platform and cemented monolithic patellar component;

c.3.35 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, mobile bearing, cementless tibia platform and cemented composite patellar component;

c.3.36 Multicompartmental total arthroplasty system, unrestricted, with cementless femoral component, mobile bearing, cementless tibia platform and cementless composite patellar component;

c.4 Multicompartmental total arthroplasty with ceramic femoral component, modular tibial component (tibia platform and fixed bearing) and taking into consideration only unrestricted cemented ceramic femoral components:

c.4.1 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, fixed bearing, cemented tibia platform and cemented monolithic patellar component;

c.4.2 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, fixed bearing, cemented tibia platform and cemented composite patellar component;

c.4.3 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, fixed bearing, cemented tibia platform and cementless composite patellar component;

c.4.4 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, fixed bearing, cementless tibia platform and cemented monolithic patellar component;

c.4.5 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, fixed bearing, cementless tibia platform and cemented composite patellar component;

c.4.6 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, fixed bearing, cementless tibia platform and cementless composite patellar component;

c.4.7 Multicompartmental total arthroplasty system, unrestricted, with cemented femoral component, mobile bearing, cemented tibia platform and cemented monolithic patellar component;

c.4.8 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, mobile bearing, cemented tibia platform and cemented composite patellar component;

c.4.9 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, mobile bearing, cemented tibia platform and cementless composite patellar component;

c.4.10 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, mobile bearing, cementless tibia platform and cemented monolithic patellar component;

c.4.11 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, mobile bearing, cementless tibia platform and cemented composite patellar component;

c.4.12 Multicompartmental total arthroplasty system, restricted, with cemented femoral component, mobile bearing, cementless tibia platform and cementless composite patellar component;

2.4 Description of possible families of knee joint replacement components:

d) Total multicompartmental arthroplasty

d.1 Cemented metal femoral component, restricted

d.2 Cemented metal femoral component, unrestricted

d.3 Cementless metal femoral component, restricted

d.4 Cementless metal femoral component, unrestricted

d.5 Cemented ceramic femoral component, unrestricted

d.6 Non-modular monolithic tibial component (polymer / cemented)

d.7 Non-modular composite tibial component without stabiliser (polymer-metal / cemented)

d.8 Non-modular composite tibial component with stabiliser (polymer-metal / cemented)

d.9 Tibia platform, cemented (metal)

d.10 Tibia platform, cementless (metal)

d.11 Fixed bearing with stabiliser (polymer)

d.12 Fixed bearing without stabiliser (polymer)

d.13 Mobile bearing (polymer / without stabiliser)

d.14 Cemented monolithic polymer patella

d.15 Cementless monolithic polymer patella

d.16 Cemented monolithic metal patella

d.17 Cementless monolithic metal patella

d.18 Cemented composite patella (polymer / metal base)

d.19 Cementless composite patella (polymer / metal base)

2.5 Description of possible accessories for families of implantable knee joint replacement components and systems:

2.5.1 Accessories for tibial components (where applicable to the product): spacers, wedges and pins.

2.5.2 Accessories for femoral components (where applicable to the product): pins and screws.

PART 3 – SHOULDER JOINT

3.1 The following criteria apply to specific parts for grouping shoulder joint replacements into families and systems for registers:

CRITERIA COMPONENTS


Composition (monolithic/composite) Glenoid component

Method of fixation (cemented/cementless) - Pin - Glenoid component

Modularity (modular/not modular) Association of head – humeral stem.

3.2 In addition to the criteria specified in the previous item, the following specific criteria apply to shoulder joint replacement systems:


Functionality - Partial - Unrestricted

Scope of implant – with or without glenoid - Partial

arthroplasty. - Total


Range of intracomponent motion – centrality of joint

- Monopolar - Bipolar

Extent of compartmentalisation of the system Unicompartmental only

Joint containment structure - Constrained standard - Constrained reverse

3.3 Description of possible shoulder joint replacement systems:

a) Constrained total arthroplasty:

a.1 – constrained total arthroplasty:

a.2 – constrained reverse total arthroplasty:

b) Unconstrained total arthroplasty:

b.1 Modular systems for unconstrained partial arthroplasties (without glenoid component):

b.1.1 – Modular systems for unconstrained modular partial arthroplasties, cemented;

b.1.2 – Modular systems for unconstrained modular partial arthroplasties, cementless;

b.1.3 – Modular systems for unconstrained non-modular partial arthroplasties, cemented;

b.1.4 – Modular systems for unconstrained non-modular partial arthroplasties, cementless.

b.2 Modular systems for unconstrained total arthroplasties (without glenoid component):

b.2.1 Modular systems for unconstrained total arthroplasties with a modular, cemented humeral shaft, monolithic metal glenoid component, cemented:

b.2.2 Modular systems for unconstrained total arthroplasties with a modular, cemented humeral shaft, monolithic polymer glenoid component, cemented:

b.2.3 Modular systems for unconstrained total arthroplasties with a modular, cemented humeral shaft, composite polymer/metal glenoid component, cemented:

b.2.4 Modular systems for unconstrained total arthroplasties with a modular, cemented humeral shaft, composite polymer/metal glenoid component, cementless:

b.2.5 Modular systems for unconstrained total arthroplasties with a modular, cementless humeral shaft, monolithic metal glenoid component, cemented:

b.2.6 Modular systems for unconstrained total arthroplasties with a modular, cementless humeral shaft, monolithic polymer glenoid component, cemented:

b.2.7 Modular systems for unconstrained total arthroplasties with a modular, cementless humeral shaft, composite polymer/metal glenoid component, cementless:

b.2.8 Modular systems for unconstrained total arthroplasties with a modular, cementless humeral shaft, composite polymer/metal glenoid component, cementless.

c) Systems for total unconstrained bipolar arthroplasties of part of the epiphysis:

c.1 – Systems for total unconstrained bipolar arthroplasties of part of the epiphysis with a modular, cemented metal shaft, metal head and bipolar component;

c.2 – Systems for total unconstrained bipolar arthroplasties of part of the epiphysis with a cementless metal shaft, metal head and bipolar component.

d) Unconstrained resurfacing arthroplasty:

d.1 Total systems for resurfacing arthroplasties with a monolithic metal glenoid component, cemented;

d.2 Total systems for resurfacing arthroplasties with a monolithic polymer glenoid component, cemented;

d.3 Total systems for resurfacing arthroplasties with a composite metal/polymer glenoid component, cemented;

d.4 Total systems for resurfacing arthroplasties with a composite metal/polymer glenoid component, cementless;

3.4 Description of possible families of shoulder joint replacement components:

a) Unconstrained arthroplasty – total and resurfacing:

a.1 Family of non-modular metal shafts, cemented;

a.2 Family of non-modular metal shafts, cementless;

a.3 Family of modular headless metal shafts, cemented;

a.4 Family of modular headless metal shafts, cementless;

a.5 Family of metal heads, cemented, for total arthroplasties;

a.6 Family of metal heads, cemented, for resurfacing arthroplasties;

a.7 Family of bipolar metal/polymer adaptation mechanisms, press fit;

a.8 Family of monolithic polymer glenoid components, cemented;

a.9 Family of monolithic metal glenoid components, cemented;

a.10 Family of composite (metal/polymer) glenoid components, cemented;

a.11 Family of composite (metal/polymer) glenoid components, cementless.

b) Constrained total arthroplasty:

b.1 Family of metal heads for constrained arthroplasties;

b.2 Family of composite (metal/polymer) constrained glenoid components, cemented.

c) Constrained reverse total arthroplasty:

c.1 Family of constraint devices for composite (metal/polymer) glenoid components; c.2 Family of monolithic metal glenoid components, cemented, for reverse total arthroplasty.

3.5 Description of possible accessories for families of implantable shoulder joint replacement components and systems: screws and meshes.

PART 4 – ELBOW JOINT

4.1 The following criteria apply to specific parts for grouping elbow joint replacements into families and systems for registers:

CRITERIA COMPONENTS


Composition (monolithic/composite) Bearing

Method of fixation (cemented/cementless) Pin and bearing.

Modularity (modular/not modular) Association of head – radial stem.

4.2 In addition to the criteria specified in the previous item, the following specific criteria apply to elbow joint replacement systems:


Functionality - Restricted - Partial - Unrestricted

Scope of implant – with or without preservation of one of the radiohumeral joint surfaces.

- Partial - Total


Range of intracomponent motion – centrality of radiohumeral joint

- Monopolar - Bipolar

Extent of compartmentalisation of the system (radiohumeral / humeroulnar)

- Multicompartmental - Unicompartmental

Joint containment structure Anatomical

4.3 Description of possible elbow joint replacement systems:

a) Systems for unrestricted total elbow arthroplasty:

a.1 Unrestricted total elbow arthroplasty, with cemented humeral component, cemented ulnar component, monolithic polymer ulnar shaft and monopolar radial component;

a.2 Unrestricted total elbow arthroplasty, with cemented humeral component, cemented ulnar component, monolithic polymer ulnar shaft and bipolar radial component;

a.3 Unrestricted total elbow arthroplasty, with cemented humeral component, cemented ulnar component, composite (metal / polymer) ulnar shaft and monopolar radial component;

a.4 Unrestricted total elbow arthroplasty, with cemented humeral component, cemented ulnar component, composite (metal / polymer) ulnar shaft and bipolar radial component;

a.5 Unrestricted total elbow arthroplasty, with cemented humeral component, cementless ulnar component, monolithic polymer ulnar shaft and monopolar radial component;

a.6 Unrestricted total elbow arthroplasty, with cemented humeral component, cementless ulnar component, monolithic polymer ulnar shaft and bipolar radial component;

a.7 Unrestricted total elbow arthroplasty, with cemented humeral component, cementless ulnar component, composite (metal / polymer) ulnar shaft and monopolar radial component;

a.8 Unrestricted total elbow arthroplasty, with cemented humeral component, cementless ulnar component, composite (metal / polymer) ulnar shaft and bipolar radial component;

a.9 Unrestricted total elbow arthroplasty, with cementless humeral component, cemented ulnar component, monolithic polymer ulnar shaft and monopolar radial component;

a.10 Unrestricted total elbow arthroplasty, with cementless humeral component, cemented ulnar component, monolithic polymer ulnar shaft and bipolar radial component;

a.11 Unrestricted total elbow arthroplasty, with cementless humeral component, cemented ulnar component, composite (metal / polymer) ulnar shaft and monopolar radial component;

a.12 Unrestricted total elbow arthroplasty, with cementless humeral component, cemented ulnar component, composite (metal / polymer) ulnar shaft and bipolar radial component;

a.13 Unrestricted total elbow arthroplasty, with cementless humeral component, cementless ulnar component, monolithic polymer ulnar shaft and monopolar radial component;

a.14 Unrestricted total elbow arthroplasty, with cementless humeral component, cementless ulnar component, monolithic polymer ulnar shaft and bipolar radial component;

a.15 Unrestricted total elbow arthroplasty, with cementless humeral component, cementless ulnar component, composite (metal / polymer) ulnar shaft and monopolar radial component;

a.16 Unrestricted total elbow arthroplasty, with cementless humeral component, cementless ulnar component, composite (metal / polymer) ulnar shaft and bipolar radial component.

4.4 Description of possible families of elbow joint replacement components:

a) Partial and total arthroplasty

a.1 Metal humeral component, cemented;

a.2 Metal humeral component, cementless;

a.3 Metal ulnar component, cemented;

a.4 Metal ulnar component, cementless;

a.5 Polymer ulnar component, cemented;

a.6 Composite (polymer/metal) ulnar component, cemented;

a.7 Non-modular monolithic polymer radial component;

a.8 Non-modular monolithic metal radial component;

a.9 Non-modular composite(metal / polymer) radial component;

a.10 Modular monopolar radial component;

a.11 Modular bipolar radial component;

a.12 Bipolar adaptation mechanism;

a.13 Humeral resurfacing arthroplasty component, cemented.

4.5 Description of possible accessories for families of implantable elbow joint replacement components and systems: screws and reinforcement mesh for pins.

PART 5 – ANKLE JOINT

5.1 The following criteria apply to specific parts for grouping ankle joint replacements, i.e. the tibia-talus and fibular-malleolar interface, into families and systems for registers:

CRITERIA COMPONENTS


Method of fixation (cemented/cementless) - Tibia platform - Talar component

5.2 In addition to the criteria specified in the previous item, the following specific criteria apply to ankle joint replacement systems:

CRITERIA APPLICABLE TO THE SYSTEM* SPECIFICATION

Composition - Monolithic - Composite

Functionality Partial

Modularity Modular

Scope of implant Total

Extent of interference with the epiphysis Full

Range of intracomponent motion Fixed

Extent of compartmentalisation of the system Unicompartmental


5.3 Description of possible ankle joint replacement systems:

5.3.1 System for ankle arthroplasty with cemented tibia platform and cemented talar component;

5.3.2 System for ankle arthroplasty with cemented tibia platform and cementless talar component;

5.3.3 System for ankle arthroplasty with cementless tibia platform and cemented talar component;

5.3.4 System for ankle arthroplasty with cementless tibia platform and cementless talar component;

5.4 Description of possible families of ankle joint replacement components:

5.4.1 Family of metal tibia platforms, cemented.

5.4.2 Family of metal tibia platforms, cementless.

5.4.3 Family of polymer joint bearings;

5.4.4 Family of metal talar components, cementless;

5.4.5 Family of metal talar components, cemented.

PART 6 – WRIST JOINT

6.1 The following criteria apply to specific parts for grouping wrist joint replacements into families and systems for registers:

CRITERIA COMPONENTS


Modularity - Radial component - Carpal component

Method of fixation (cemented/cementless) - Radial component - Carpal component

6.2 In addition to the criteria specified in the previous item, the following specific criteria apply to wrist joint replacement systems:


Composition Monolithic

Functionality Partial

Scope of implant Total



Extent of compartmentalisation of the system - Unicompartmental radiocarpal - Unicompartmental radiocarpal and distal radioulnar


6.3 Description of possible wrist joint replacement systems:

6.3.1 Unicompartmental system with radial joint bearing, modular cemented radial component and non-modular cemented carpal component;

6.3.2 Unicompartmental system with radial joint bearing, modular cemented radial component and non-modular cementless carpal component;

6.3.3 Unicompartmental system with radial joint bearing, modular cementless radial component and non-modular cemented carpal component;

6.3.4 Unicompartmental system with radial joint bearing, modular cementless radial component and non-modular cementless carpal component;

6.3.5 Unicompartmental system with carpal post, non-modular cemented radial component and modular cemented carpal component;

6.3.6 Unicompartmental system with carpal post, non-modular cemented radial component and modular cementless carpal component;

6.3.7 Unicompartmental system with carpal post, non-modular cementless radial component and modular cemented carpal component;

6.3.8 Unicompartmental system with carpal post, non-modular cementless radial component and modular cementless carpal component;

6.3.9 Multicompartmental systems (modular radial component with radial joint bearing and metal ulnar pin), cemented radial component, cemented carpal component, and metal ulnar extremity;

6.3.10 Multicompartmental systems (modular radial component with radial joint bearing and metal ulnar pin), cemented radial component, cemented carpal component, and non-metal ulnar extremity;

6.3.11 Multicompartmental systems (modular radial component with radial joint bearing and metal ulnar pin), cemented radial component, cementless carpal component, and metal ulnar extremity;

6.3.12 Multicompartmental systems (modular radial component with radial joint bearing and metal ulnar pin), cemented radial component, cementless carpal component, and non-metal ulnar extremity;

6.3.13 Multicompartmental systems (modular radial component with radial joint bearing and metal ulnar pin), cementless radial component, cemented carpal component, and metal ulnar extremity;

6.3.14 Multicompartmental systems (modular radial component with radial joint bearing and metal ulnar pin), cementless radial component, cemented carpal component, and non-metal ulnar extremity;

6.3.15 Multicompartmental systems (modular radial component with radial joint bearing and metal ulnar pin), cementless radial component, cementless carpal component, and metal ulnar extremity;

6.3.16 Multicompartmental systems (modular radial component with radial joint bearing and metal ulnar pin), cementless radial component, cementless carpal component, and non-metal ulnar extremity;

6.4 Description of possible families of wrist joint replacement components:

6.4.1 Family of modular unicompartmental radial components, cemented;

6.4.2 Family of modular unicompartmental radial components, cementless;

6.4.3 Family of non-modular unicompartmental radial components, cemented;

6.4.4 Family of non-modular unicompartmental radial components, cementless;

6.4.5 Family of modular multicompartmental radial components, cemented;

6.4.6 Family of modular multicompartmental radial components, cementless;

6.4.7 Family of modular carpal components, cemented;

6.4.8 Family of modular carpal components, cementless;

6.4.9 Family of modular carpal components, cemented;

6.4.10 Family of modular carpal components, cementless;

6.4.11 Family of polymer carpal bearings;

6.4.12 Family of polymer radial joint bearings;

6.4.13 Family of polymer ulnar extremities;

6.4.14 Family of metal ulnar extremities;

6.4.15 Family of ulnar pins.

PART 7 – TEMPOROMANDIBULAR JOINT

7.1 The following criteria apply to specific parts for grouping temporomandibular joint replacements into families and systems for registers:

CRITERIA COMPONENTS


Method of fixation (cemented/cementless) Mandibular fossa component

Modularity Condylar component

Plates and screws (fixation system for the condylar component)

Structure – rigidity (rigid fixation / intermaxillary fixation)*

* Specific criterion.

7.2 In addition to the criteria specified in the previous item, the following specific criteria apply to temporomandibular joint replacement systems:


Composition Monolithic

Functionality Unrestricted

Scope of implant – with or without preservation of the surface of the mandibular fossa.

- Total – mandibular fossa not preserved - Partial – mandibular fossa preserved



Extent of compartmentalisation of the system Unicompartmental


7.3 Description of possible temporomandibular joint replacement systems:

7.3.1 Total arthroplasty system for the TMJ with modular condylar component, cemented temporal component and rigid fixation (plate/screws);

7.3.2 Total arthroplasty system for the TMJ with modular condylar component, cementless temporal component and rigid fixation (plate/screws);

7.3.3 Total arthroplasty system for the TMJ with modular condylar component, cemented temporal component and intermaxillary fixation (plate/screws);

7.3.4 Total arthroplasty system for the TMJ with modular condylar component, cementless temporal component and intermaxillary fixation (plate/screws);

7.3.5 Total arthroplasty system for the TMJ with non-modular condylar component, cemented temporal component and rigid fixation (plate/screws);

7.3.6 Total arthroplasty system for the TMJ with non-modular condylar component, cementless temporal component and rigid fixation (plate/screws);

7.3.7 Total arthroplasty system for the TMJ with non-modular condylar component, cemented temporal component and intermaxillary fixation (plate/screws);

7.3.8 Total arthroplasty system for the TMJ with non-modular condylar component, cementless temporal component and intermaxillary fixation (plate/screws);

7.3.9 Partial arthroplasty system for the TMJ with modular condylar component and rigid fixation (plate/screws);

7.3.10 Partial arthroplasty system for the TMJ with modular condylar component and intermaxillary fixation (plate/screws);

7.3.11 Partial arthroplasty system for the TMJ with non-modular condylar component and rigid fixation (plate/screws);

7.3.12 Partial arthroplasty system for the TMJ with non-modular condylar component and intermaxillary fixation (plate/screws);

7.4 Description of possible families of temporomandibular joint replacement components:

7.4.1 Family of metal condylar components;

7.4.2 Family of polymer condylar components;

7.4.3 Family of metal temporal components;

7.4.4 Family of polymer temporal components.

7.5 The plates and screws used to fix the condylar components must be classified according to the criteria for the grouping into families of plates and families of screws set out in the specific regulation.

PART 8 – INTERSOMATIC SPACER WITH INTRINSIC MOBILITY – DISC PROSTHESES FOR THE SPINAL COLUMN

8.1 Only the modularity and composition criteria will be taken into account for grouping intersomatic spacers with intrinsic mobility into families.

8.2 For the register, these devices will be considered single composite products.

8.3 Description of possible families of intersomatic spacers with intrinsic mobility:

8.3.1 Family of modular monolithic intersomatic spacers with intrinsic mobility;

8.3.2 Family of non-modular monolithic intersomatic spacers with intrinsic mobility;

8.3.3 Family of modular composite intersomatic spacers with intrinsic mobility;

8.3.4 Family of non-modular composite intersomatic spacers with intrinsic mobility;

PART 9 – SINGLE COMPOSITE PRODUCTS

9.1 With regard to Item 5.4 of Part 5, “Requirements” of the technical regulation containing the general requirements for grouping ORTHOPAEDIC IMPLANTS into families and systems for registers, the following items may be included in the register for single composite products:

9.1.1 Implants for wholly restricted arthroplasty of elbows and knees;

9.1.2 Implants for resurfacing the femur, cemented.

9.1.3 Implants for resurfacing the femur, cementless.

9.1.4 Implants for total constrained hip arthroplasty;

9.1.5 Implants for constrained reverse total arthroplasty;

9.1.6 Implants for restricted total elbow arthroplasty, without polymer radioulnar component;

9.1.7 Implants for restricted total elbow arthroplasty, with polymer radioulnar component;

9.1.8 Implants for total interphalangeal joint arthroplasty (hands);

9.1.9 Implants for total metacarpal-phalangeal arthroplasty;

9.1.10 Implants for total metacarpal-phalangeal arthroplasty of the hallux;

PART 10 – UNCONVENTIONAL ENDOPROSTHESES

10.1 The following criteria apply to the products for grouping unconventional endoprostheses into families:

APPLICABLE CRITERIA SPECIFICATION

Joint - Monoarticulated - Biarticulated - Not articulated

Location - Lower limbs - Unconventional upper limbs

10.2 Implants with resurfacing treatments aggregating raw materials which differ from those of their production are to be grouped in a different register from implants without resurfacing treatment of this kind.

10.3 Description of possible families of unconventional endoprostheses:

10.3.1 Family of monoarticulated unconventional endoprostheses for lower limbs;

10.3.2 Family of monoarticulated unconventional endoprostheses for upper limbs;

10.3.3 Family of biarticulated unconventional endoprostheses for lower limbs;

10.3.4 Family of biarticulated unconventional endoprostheses for upper limbs;

10.3.5 Family of non-articulated unconventional endoprostheses for lower limbs;

10.3.6 Family of non-articulated unconventional endoprostheses for lower limbs.

10.4 Unconventional endoprostheses are those with special characteristics due to the anatomical particularities of the patients and the lesions associated with the location of the implant, in addition to their use in specific cases, given that they are generally used as replacements where there is no anatomical standard for placing them.

10.5 Unconventional endoprostheses may be made to measure or not, as those which have a defined technical design, even if the dimensions of the components vary, must be registered with Anvisa with regard to manufacture, import, export, display for sale or delivery to the consumer, in accordance with the criteria described above.

10.6 Unconventional endoprostheses which are made to measure, i.e. constructed from imagenological examination of specific cases , without a standard technical design, will be dealt with by a specific technical regulation.

ANNEX II

SPECIFIC CRITERIA FOR GROUPING OSTEOSYNTHESIS IMPLANTS INTO FAMILIES AND SYSTEMS FOR REGISTERS

PART 1 – PLATES FOR OSTEOSYNTHESIS

1.2 The following criteria apply to specific parts for grouping plates for osteosynthesis into families and systems for registers:

CRITERIA SPECIFICATION

Material - Absorbable - Non-absorbable

Form - Straight and special* - Angled* (sharp angle) - Angular-Tubular

Dimensions - Large and small fragments (>2.7mm**) - Mini and micro fragments (<2.7mm**)

* Special plates can be bent along the same Cartesian plane as the holes (two-dimensional deformation), while within angled plates the bending occurs in a Cartesian plane which differs from that of the perforated surface (three-dimensional deformation).

**In reference to the internal diameter of the hole in the plate.

1.2 In addition to the criteria specified in the previous item, the following specific criteria apply to plates for osteosynthesis:


Rigidity of the fixation* - Rigid fixation - Non-rigid fixation

* Rigidity refers to the presence or absence of devices which prevent movement between the plate and screw components (threaded holes or clamping systems).

1.3 Description of possible systems of non-rigid plates for osteosynthesis:

a.1) Non-rigid, non-absorbable fixation system with tube plate, sliding nail and compression or blocking screw;

a.2) Non-rigid, non-absorbable fixation system for mini and micro fragments (including deformable plates for reconstruction);

a.3) Non-rigid, absorbable fixation system for mini and micro fragments (including deformable plates for reconstruction);

1.4 Description of possible families of non-rigid plates for osteosynthesis:

b) Families of non-absorbable plates:

b.1) Family of plates for large and small fragments;

b.2) Family of plates for mini and micro fragments;

b.3) Family of angular tube plates

b.4) Family of angular plates;

c) Families of absorbable plates:

c.1) Family of plates for large and small fragments;

c.2) Family of plates for mini and micro fragments.

1.5 Rigid fixation plates for osteosynthesis, together with their rigid fixation screws, are recorded in registers of systems according to the following characteristics:

d.1) Rigid fixation system for plates for large and small fragments;

d.2) Rigid fixation system for plates for mini and micro fragments;

d.3) Rigid fixation system for angular tube plates (including the relevant sliding nail and compression or blocking screws).

d.4) Rigid fixation system for angular plates.

1.6 Rigid fixation systems permit the use of the following accessories: screw plugs, threaded spacers and washers.

PART 2 – SCREWS FOR OSTEOSYNTHESIS

2.1 The following criteria apply to specific parts for grouping screws for osteosynthesis into families and systems for registers:



Geometry - Cannulated - Uncannulated

Dimensions - Large and small fragments - Mini and micro fragments

Position - Osteosynthesis - Ligamentoplasty

Rigidity of the fixation* - Rigid fixation - Non-rigid fixation

Use (re: application to angulated plates or - Applicable

intramedullary nails) - Not applicable

* Rigidity refers to the presence or absence of devices which prevent movement between the plate and screw components (threaded holes or clamping systems).

2.2 Description of possible families of osteosynthesis screws:

a) Families of non-absorbable screws – without rigid fixation for osteosynthesis:

a.1) Family of sliding nails (compression or blocking screws), application to angulated tube plates or intramedullary nails;

a.2) Families of screws for large and small fragments, cannulated;

a.3) Families of screws for mini and micro fragments, cannulated;

a.4) Families of screws for large and small fragments, uncannulated;

a.5) Families of screws for mini and micro fragments, uncannulated;

a.6) Families of screws with clamps, cannulated;

a.7) Families of screws with clamps, uncannulated.

b) Families of non-absorbable screws – without rigid fixation for ligamentoplasty:

b.1) Families of screws for ligament fixation, uncannulated (screws and cross-nails);

b.2) Families of screws for ligament fixation, cannulated;

b.3) Families of blocking, compression, clamp and other related screws, including nails and blocking screws for intramedullary nails;

c) Families of non-absorbable screws – with rigid fixation for osteosynthesis:

c.1) Families of expandable head screws for plate fixation (a single composite product with the related clamp screw);

c.2) Families of screws for plate fixation with the lower surface of the head threaded;

d) Families of absorbable screws – without rigid fixation for osteosynthesis:

d.1) Families of screws for large and small fragments, cannulated;

d.2) Families of screws for mini and micro fragments, cannulated;

d.3) Families of screws for large and small fragments, uncannulated;

d.4) Families of screws for mini and micro fragments, uncannulated;

e) Families of non-absorbable screws – without rigid fixation for ligamentoplasty:

e.1) Ligament fixation, uncannulated (screws and cross-nails);

e.2) Ligament fixation, cannulated.

f) Families of non-absorbable screws – without rigid fixation for ligamentoplasty:

f.1) Ligament fixation, uncannulated (screws and cross-nails);

f.2) Ligament fixation, cannulated.

2.3 Washers and bolts are the accessories permitted for these products.

PART 3 – OSTEOSYNTHESIS CLIPS

3.1 Only the material criterion, without any specific criteria, will be taken into account for grouping osteosynthesis clips into families.

3.2 Clips which are part of a device will be classified with that component as sets or kits for the purpose of a register.

3.3 Description of possible families of osteosynthesis clips:

3.3.1 Families of clips with an absorbable component;

3.3.2 Families of clips with a non-absorbable component.

PART 4 - FLEXIBLE WIRES AND CABLES

4.1 Only the material criterion, without any specific criteria, will be taken into account for grouping flexible wires and cables for osteosynthesis into families.

4.2 Description of possible families of flexible wires and cables:

4.2.1 Family of metal non-absorbable flexible wires and cables;

4.2.2 Family of non-metallic non-absorbable flexible wires and cables;

4.2.3 Family of absorbable flexible wires and cables (not including sutures).

PART 5 – NAILS AND RIGID WIRES

5.1 Only the material criterion, without any specific criteria, will be taken into account for grouping nails and rigid wires for osteosynthesis into families.

5.2 Description of possible families of nails and rigid wires:

5.2.1 Family of metal non-absorbable nails and rigid wires;

5.2.2 Family of absorbable nails and rigid wires.

PART 6 – INTRAMEDULLARY NAILS

6.1 The following criteria apply to specific parts for grouping intramedullary nails into families and systems for registers:


Rigidity associated with the structure - Flexible - Semi-rigid

Method of fixation - Blocked - Not blocked

Method of blocking - Internal expansion - Exclusively by transverse screw - Mixed

Application (only for systems) - Femoral - Tibial - Humeral

6.2 Description of possible intramedullary nail systems:

6.2.1. Semi-rigid nail system with transverse blocking screw – femoral;

6.2.2. Semi-rigid nail system with transverse blocking screw – tibial;

6.2.3. Semi-rigid nail system with transverse blocking screw – humeral;

6.2.4. Semi-rigid nail system with mixed blocking – screws and sliding nail or spring – femoral;

6.2.5 Semi-rigid nail system with mixed blocking – screws and sliding nail or spring – humeral;

6.3 Description of possible intramedullary nail families:

6.3.1. Family of flexible nails;

6.3.2. Family of semi-rigid nails without blocking;

6.3.3. Family of semi-rigid nails with blocking via internal expansion;

6.3.4. Family of semi-rigid nails with blocking via transverse screws;

6.3.5. Semi-rigid nail family with mixed blocking – screws and sliding nail or spring.

6.4 The screws and nails used with the intramedullary nails are not accessories and therefore are not grouped into families for registers as they must have their own register in accordance with the criteria for grouping screws.

6.5 Screw plugs form a single composite product with intramedullary nails and must be including in the register as part of the same family.

PART 7 – ORTHOPAEDIC SUTURE ANCHORS

7.1 The following criteria apply to specific parts for grouping orthopaedic suture anchors into families and systems for registers:

CRITERION SPECIFICATION


Presence of insertion device - With device - Without device

7.2 Insertion devices may only be included as part of the product if reprocessing is prohibited and they are presented in the same way as the implants, as described below.

7.2.1 Single composite product containing an absorbable anchor and absorbable suture mounted in an insertion device;

7.2.2 Single composite product containing an absorbable anchor and non-absorbable suture mounted in an insertion device;

7.2.3 Single composite product containing a non-absorbable anchor and absorbable suture mounted in an insertion device;

7.2.4 Single composite product containing a non-absorbable anchor and non-absorbable suture mounted in an insertion device;

7.2.5 Single composite product containing a non-absorbable anchor and partially absorbable suture mounted in an insertion device;

7.2.6 Single composite product containing an absorbable anchor and partially absorbable suture mounted in an insertion device;

7.3 For the composite products described in 7.2, the only permissible variation within the same register is the dimension of the anchors.

7.4 Single composite products containing an anchor and suture may or may not include a needle.

7.5 Description of possible families of orthopaedic suture anchors:

7.5.1 Families of absorbable anchors;

7.5.2 Family of single composite products containing an absorbable anchor and absorbable suture;

7.5.3 Family of single composite products containing an absorbable anchor and non-absorbable suture;

7.5.4 Families of non-absorbable anchors;

7.5.5 Family of single composite products containing a non-absorbable anchor and non-absorbable suture;

7.5.6 Family of single composite products containing a non-absorbable anchor and absorbable suture;

7.5.7 Family of single composite products containing a non-absorbable anchor and partially absorbable suture;

7.5.8 Family of single composite products containing an absorbable anchor and partially absorbable suture;

PART 8 – GRAFT BEARING DIAPHYSEAL SPACERS

8.1 Only the material criterion, without any specific criteria, will be taken into account for grouping graft bearing diaphyseal spacers into families.

8.2 Description of possible families of graft bearing diaphyseal spacers:

8.2.1 Families of non-absorbable spacers;

8.2.2 Families of absorbable spacers.

PART 9 - IMPLANTABLE MANDIBULAR BRACES

9.1 Only the material criterion, without any specific criteria, will be taken into account for grouping implantable mandibular braces into families.

9.2 Description of possible families of implantable mandibular braces:

9.2.1 Families of non-absorbable implantable mandibular braces;

9.2.2 Families of absorbable implantable mandibular braces.

PART 10 – HALO BRACE

10.1 Halo braces are considered single composite products, comprising a metallic halo with screw holes and metal screws to fix the halo, and may be registered as single articles or families, but never as systems.

10.2 This classification includes the unthreaded cranial haloes (buttons) with or without sutures, since sutures are required for the implant to function.

10.3 Only the material criterion, without any specific criteria, will be taken into account for grouping cranial fixation apparatus into families.

10.4 Description of possible families of cranial fixation apparatus:

10.4.1 Family of non-absorbable cranial fixation apparatus;

10.4.2 Family of absorbable cranial fixation apparatus.

10.5 Connectors for plaster or polymer collars are considered accessories to this system.

ANNEX III

SPECIFIC CRITERIA FOR GROUPING SPINAL IMPLANTS INTO FAMILIES AND SYSTEMS FOR REGISTERS

PART 1 – GRAFT BEARING INTERSOMATIC SPACERS

1.1 Intersomatic spacers are considered to include vertebral spacers for replacing intervertebral disks and fusion cylinders for replacing the vertebral body and intervertebral disk.

1.2 Intersomatic spacers for replacing intervertebral disks and fusion cylinders for replacing the vertebral body and intervertebral disk must be grouped in separate registers according to their application.

1.3 The following criteria apply to specific parts for grouping graft bearing intersomatic spacers into families and systems for registers:


Indication - Disk replacement - Body and disk replacement


Architecture - Expandable - Not expandable

1.4 Description of possible families of graft bearing intersomatic spacers:

1.4.1 Families of non-absorbable, expandable, metal intersomatic spacers for replacing the disk;

1.4.2 Families of non-absorbable, non-expandable, metal intersomatic spacers for replacing the disk;

1.4.3 Families of non-absorbable, non-expandable, polymer intersomatic spacers for replacing the disk;

1.4.4 Families of non-absorbable, non-expandable, ceramic intersomatic spacers for replacing the disk;

1.4.5 Families of absorbable intersomatic spacers for replacing the disk;

1.4.6 Families of non-absorbable, expandable, metal intersomatic spacers for replacing the body and disk;

1.4.7 Families of non-absorbable, non-expandable, metal intersomatic spacers for replacing the body and disk;

1.4.8 Families of non-absorbable, non-expandable, polymer intersomatic spacers for replacing the body and disk;

1.4.9 Families of non-absorbable, non-expandable, ceramic intersomatic spacers for replacing the body and disk;

1.4.10 Families of absorbable intersomatic spacers for replacing the body and disk.

PART II – SPINAL IMPLANT SYSTEMS The following criteria apply to specific parts for grouping spinal implant systems into families and systems for registers:


Materials - Metal - Polymer - Ceramic

Rigidity associated with the structure - Flexible

- Rigid

Fixation structures - Bars and wires - Plates and screws - Nails/screws/hooks.

Direction of implant - Anterior - Posterior / postero-lateral

3.2 Description of possible anterior systems for intersomatic fixation:

3.2.1 Metal anterior systems for intersomatic fixation using plates (Metal plates, metal screws for plate fixation with or without clamping system, screws to clamp the fixation screws);

3.2.2. Non-absorbable polymer anterior systems for intersomatic fixation using plates (Polymer plates, metal or polymer screws for plate fixation with or without clamping system, screws to clamp the fixation screws).

3.2.3. Anterior systems for intersomatic fixation with connecting pins (Devices for fixation to the vertebral body, screws with or without clamping system for coupling the pin and affixing the devices to the vertebral body, screws to clamp the fixation screws, connecting pins).

3.3 Description of posterior systems for intersomatic fixation:

3.3.1 Posterior systems of flexible components with pedicle screws (Flexible cables, pedicle screw);

3.3.2 Rigid posterior systems with flat bars fixed by wires - peripheral fixation to the lamina, pedicle or apophysis (laminar hooks, metal wires, polymer wires);

3.3.3 Rigid posterior systems with metal plates fixed by intrasomatic screws – through the pedicle or the body of the joint (straight and/or hooked plate, fixation screws);

3.3.4. Rigid posterior systems with non-absorbable polymer plates fixed by intrasomatic screws – through the pedicle or the body of the joint (straight and/or hooked plate, metal and/or polymer fixation screws);

3.3.5. Rigid posterior systems with pins fixed by intrasomatic or intraoccipital screws and/or hooks - peripheral fixation to the lamina, pedicle or apophysis (wires fixed by laminar hooks, laminar hooks, pedicle hooks, apophyseal hooks, occipital screws, mono-axial / poly-axial pedicle screws, clamping screws, blocking screws, connectors, ball and socket joints, stabilisers).

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