DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ... · 10/28/2016 · 5079-5-150 Stainless...
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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Surgical Instrument Service and Savings Inc. Brandi J. Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756 Re: K163028 Trade/Device Name: Medline ReNewal Reprocessed Stryker External Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JEC Dated: October 28, 2016 Received: October 31, 2016 Dear Brandi Panteleon: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device- related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. December 28, 2016
Transcript of DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ... · 10/28/2016 · 5079-5-150 Stainless...
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration10903 New Hampshire AvenueDocument Control Center - WO66-G609Silver Spring, MD 20993-0002
Surgical Instrument Service and Savings Inc.Brandi J. PanteleonDirector, Quality Assurance and Regulatory Affairs2747 SW 6th St.Redmond, Oregon 97756
Re: K163028Trade/Device Name: Medline ReNewal Reprocessed Stryker External Fixation DevicesRegulation Number: 21 CFR 888.3040Regulation Name: Smooth or threaded metallic bone fixation fastenerRegulatory Class: Class IIProduct Code: JECDated: October 28, 2016Received: October 31, 2016
Dear Brandi Panteleon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
December 28, 2016
- Brandi J. PanteleonPage 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark MelkersonDivision Director Division of Orthopedic DevicesOffice of Device EvaluationCenter for Devices and Radiological Health
Enclosure:Reprocessed List
for
Caroline Rhim -S
- Brandi J. PanteleonPage 3
Part Number Description4920-1-010 Rod to Rod Coupling for 8mm rods or posts4920-1-020 Pin to Rod Coupling for 4-5mm pins/8mm rods or posts4920-1-030 Inverted Pin to Rod Coupling for 8mm rods or posts/4-5mm pins4920-1-100 Tube to Rod Coupling for 20mm tubes/8mm rods or posts4920-2-020 5 Hole Pin Clamp for 4/5/6mm pins4920-2-060 10-Hole Pin Clamp for 4/5/6mm pins4920-2-080 Pelvic Clamp for 4/5/6mm pins4920-2-120 Straight Post 8mm4920-2-140 30° Angled Post 8mm4920-2-160 90° Angled Post 8mm4920-2-181 HII THREADED POST W 13mm NUT4920-9-020 Removable Thumbwheel4940-1-010 Rod to Rod Coupling for Ø5mm rods or posts4940-1-015 HII Compact Baltimore Coupling4940-1-020 Pin to Rod Coupling- Ø5mm rods or posts/Ø3-4mm pins4940-1-058 Rod to Rod Coupling-Ø8mm rods, posts/Ø5mm rods, posts4940-1-100 Tube to Rod Coupling - Ø15mm tube/Ø5mm rods or posts4940-2-020 Hoffmann 2 Compact Pin Clamp 4 hole Pin Clamp-Ø3 and Ø4mm pins4940-2-120 Straight Post Ø5mm4940-2-140 30° Angled Post Ø5mm4940-2-200 Peri-Articular Pin Clamp for Ø3mm pins4960-1-010 Micro Rod to Rod Coupling 3mm/3mm4960-1-020 Micro Pin to Rod Coupling 1.65mm-2mm/3mm4960-1-060 Micro Rod to Rod Coupling 5mm/3mm4960-2-020 Micro Multi-Pin Clamp4960-2-030 90° Micro Multi-Pin Clamp4960-3-020 HII Micro Lengthener Pin Clamp4960-3-030 HII Micro Lengthener Thumbwheel5029-1-611 Ball Joint 5 Hole Double Parallel5029-8-805 Carbon Connecting Rod 8mm x 65mm5029-8-810 Carbon Connecting Rod 8mm x 100mm5029-8-815 Carbon Connecting Rod 8mm x 150mm5029-8-820 Carbon Connecting Rod 8mm x 200mm5029-8-825 Carbon Connecting Rod 8mm x 250mm5029-8-830 Carbon Connecting Rod 8mm x 300mm5029-8-835 Carbon Connecting Rod 8mm x 350mm5029-8-840 Carbon Connecting Rod 8mm x 400mm5029-8-845 Carbon Connecting Rod 8mm x 450mm5029-8-850 Carbon Connecting Rod 8mm x 500mm5049-5-065 Stainless Steel Connecting Rod Ø5mm x 65mm5049-5-100 Stainless Steel Connecting Rod Ø5mm x 100mm5049-5-150 Stainless Steel Connecting Rod Ø5mm x 150mm5049-5-200 Stainless Steel Connecting Rod Ø5mm x 200mm5049-5-250 Stainless Steel Connecting Rod Ø5mm x 250mm5049-5-300 Stainless Steel Connecting Rod Ø5mm x 300mm5049-5-505 Carbon Connecting Rod Ø5mm x 65mm5049-5-510 Carbon Connecting Rod Ø5mm x 100mm5049-5-515 Carbon Connecting Rod Ø5mm x 150mm5049-5-520 Carbon Connecting Rod Ø5mm x 200mm5049-5-525 Carbon Connecting Rod Ø5mm x 250mm5049-5-530 Carbon Connecting Rod Ø5mm x 300mm5049-7-018 Semi Circular Curved Rod-Stainless Steel Ø5mm x 111mm5049-7-020 Semi Circular Curved Rod-Stainless Steel Ø5mm x 146mm5079-5-030 Stainless Steel Connecting Rod 3mm x 30mm5079-5-040 Stainless Steel Connecting Rod 3mm x 40mm5079-5-050 Stainless Steel Connecting Rod 3mm x 50mm5079-5-060 Stainless Steel Connecting Rod 3mm x 600mm5079-5-070 Connecting Rod 3mm x 70mm5079-5-090 Stainless Steel Connecting Rod 3mm x 90mm5079-5-120 Stainless Steel Connecting Rod 3mm x 120mm5079-5-150 Stainless Steel Connecting Rod 3mm x 150mm5079-5-180 Connecting Rod 3mm x 180mm5079-5-250 Connecting Rod 3mm x 250mm5079-5-300 Connecting Rod 3mm x 300mm5079-6-030 Carbon Connecting Rod 3mm x 30mm5079-6-040 Carbon Connecting Rod 3mm x 40mm5079-6-050 Carbon Connecting Rod 3mm x 50mm5079-6-060 Carbon Connecting Rod 3mm x 60mm5079-6-090 Carbon Connecting Rod 3mm x 90mm5079-6-120 Carbon Connecting Rod 3mm x 120mm5079-6-150 Carbon Connecting Rod 3mm x 150mm
Hoffmann II
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Part Number Description4921-1-010 MR conditional 8mm Rods or Posts, Rod to Rod Coupling (Gold Hardware)
4921-1-020MR conditional Pin to Rod Coupling for Ø4-5mm pins/Ø8mm rods or posts (Gold Hardware)
4921-1-030MR conditional Inverted Pin to Rod Coupling for Ø8mm rods or posts/Ø4-5mm pins (Gold Hardware)
4921-1-100MR conditional Tube to Rod Coupling for Ø20mm tubes/Ø8mm rods or posts (Gold Hardware)
4921-2-020 MR conditional 5-Hole Pin Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware)4921-2-060 MR conditional 10-Hole Pin Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware)4921-2-080 MR conditional Pelvic Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware)4921-2-120 MR conditional Straight Post Ø8mm (Gold Tip)4921-2-140 MR conditional 30° Angled Post Ø8mm (Gold Tip)4941-1-010 MR conditional rod to Rod Coupling for Ø5mm rods or posts4941-1-020 MR conditional Pin to Rod Coupling for Ø5mm rods or posts/Ø3-4mm pins4941-1-058 MR conditional Rod to Rod Coupling for Ø8mm rods or posts/Ø5mm rods or posts4941-1-100 MR conditional Tube to Rod Coupling for Ø15mm tube/Ø5mm rods or posts4941-2-120 MR conditional 30° Angled Post Ø5mm4941-2-140 MR conditional 4941-2-140 30° Angled Post Ø5mm4941-2-200 MR conditional Peri-Articular Pin Clamp for Ø3mm pins5028-7-030 MR conditional Semi-Circular Carbon Rod 174mm (L)5028-8-065 MR conditional Carbon Connecting Rod 65mm Ø8mm (Yellow)5028-8-100 MR conditional Carbon Connecting Rod 100mm Ø8mm (Yellow)5028-8-150 MR conditional Carbon Connecting Rod 150mm Ø8mm (Yellow)5028-8-200 MR conditional Carbon Connecting Rod 200mm Ø8mm (Yellow)5028-8-250 MR conditional Carbon Connecting Rod 250mm Ø8mm (Yellow)5028-8-300 MR conditional Carbon Connecting Rod 300mm Ø8mm (Yellow)5028-8-350 MR conditional Carbon Connecting Rod 350mm Ø8mm (Yellow)5028-8-400 MR conditional Carbon Connecting Rod 400mm Ø8mm (Yellow)5028-8-450 MR conditional Carbon Connecting Rod 450mm Ø8mm (Yellow)5028-8-500 MR conditional Carbon Connecting Rod 500mm Ø8mm (Yellow)5048-5-065 MR conditional Carbon Connecting Rod 65mm Ø5mm (Yellow)5048-5-100 MR conditional Carbon Connecting Rod 100mm Ø5mm (Yellow)5048-5-150 MR conditional Carbon Connecting Rod 150mm Ø5mm (Yellow)5048-5-200 MR conditional Carbon Connecting Rod 200mm Ø5mm (Yellow)5048-5-250 MR conditional Carbon Connecting Rod 250mm Ø5mm (Yellow)5048-5-300 MR conditional Carbon Connecting Rod 300mm Ø5mm (Yellow)4921-2-020 AHS MR conditional 5 HOLE PIN CLAMP4921-2-160 MR conditional 90 DEGREE POST4941-2-020 4 hole pin clamp for Ø3 and Ø4mm pins
Hoffmann II MR Conditional (3.0 T)
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Part Number Description
4922-1-010Delta Coupling, Rod-to-Rod or Pin-to-Rod, Ø5/8/11mm Rods and Ø5mm Apex Pins
4922-1-020 Delta Coupling, Pin-to-Rod, Ø5/8/11mm Rods and Ø4/5/6mm Apex Pins
4922-1-030Delta Coupling, Pin-to-Rod, inverted, Ø5/8/11mm Rods and Ø4/5/6mm Apex Pins
4922-2-020 5-Hole Pin Clamp4922-2-120 Straight Post Ø11mm4922-2-140 30° Angled Post Ø11mm4922-2-160 90° Angled Post Ø11mm4922-2-220 5-Hole Pin Clamp with two Ø11mm Straight Posts4922-2-240 5-Hole Pin Clamp with two Ø11mm 30° Angled Posts4922-2-320 5-Hole Pin Clamp with one Ø11mm Straight Post4922-2-340 5-Hole Pin Clamp with one Ø11mm 30° Angled Post4922-8-100 Ø11mm Vectran coated Carbon Connecting Rods 100mm4922-8-150 Ø11mm Vectran coated Carbon Connecting Rods 150mm4922-8-200 Ø11mm Vectran coated Carbon Connecting Rods 200mm4922-8-250 Ø11mm Vectran coated Carbon Connecting Rods 250mm4922-8-300 Ø11mm Vectran coated Carbon Connecting Rods 300mm4922-8-350 Ø11mm Vectran coated Carbon Connecting Rods 350mm4922-8-400 Ø11mm Vectran coated Carbon Connecting Rods 400mm4922-8-450 Ø11mm Vectran coated Carbon Connecting Rods 450mm4922-8-500 Ø11mm Vectran coated Carbon Connecting Rods 500mm4922-8-550 Ø11mm Vectran coated Carbon Connecting Rods 550mm4922-8-600 Ø11mm Vectran coated Carbon Connecting Rods 600mm4922-8-650 Ø11mm Vectran coated Carbon Connecting Rods 650mm
Hoffmann III MR Conditional (1.5 T)
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510(k) Summary K163028
Submitter/ Owner
Surgical Instrument Service and Saving Inc. dba Medline ReNewal 2747 SW 6th St. Redmond, OR 97756
Contact Name
Brandi Panteleon Director, Quality Assurance and Regulatory Affairs P: 541-516-4180 F: 541-923-3375 E: [email protected]
Prepared by
Stephanie Boyle Mays Regulatory Affairs Specialist, Regulatory Affairs P: 541-516-4205 F: 541-923-3375 E:[email protected]
Date Prepared October 28, 2016
Device Names
Proprietary Name: Medline ReNewal Reprocessed Stryker External Fixation Devices Common Name: External Fixation Devices, Fixation Appliance, single/multiple component (component)
Classification
Classification: Class II Classification Name: Single/multiple component metallic bone fixation appliances and accessories and smooth or threaded metallic bone fixation fastener. Regulation Number/Product Code: 888.3030/JEC (subsequent code LXT); 888.3040/JEC; and 888.3030/KTT
Predicate Device
K102885 Stryker Hoffman II External Fixation System Line Extension Model 4920-1-010, 4920-1-020; 4920-1-030, 4920-1-100, Hoffmann II EX
Reference Device 1
K952730 Howmedica Hoffmann II External Fixation System
Reference Device 2
K122284 Stryker Hoffmann 3 Modular External Fixation System
Device Description
The Medline ReNewal Reprocessed Stryker External Fixation Devices are intended to provide temporary stabilization of open and/or unstable fractures where soft tissue injury may preclude the use of other fracture treatments. Additionally, the devices may be used for elective orthopedic interventions such as limb lengthening. Devices in the scope of this document include various rods and clamps/connectors that are assembled external to the operative or injury focus and will not be in direct patient contact.
Statement of Intended Use
The Medline ReNewal Reprocessed Stryker External Fixation Devices are components in an external fixation system that is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other means of fixation.
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Indications
The Medline ReNewal Reprocessed Stryker External Fixation Devices are external fixation frame components for use with components of the Hoffman 3 MR Conditional, Hoffmann II MR Conditional, Hoffmann II, Hoffmann II Compact MR Conditional and Hoffmann II Compact external fixation systems. They are intended to provide stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other mean of internal fixation The indications for use of external fixation devices include: bone fracture fixation; osteotomy; arthrodesis; correction of deformity; revision procedure where other treatments or
devices have been unsuccessful; and bone reconstruction procedures.
Technological Characteristics
The Medline ReNewal Reprocessed Stryker External Fixation Devices are rods, couplings, connectors, clamps, posts and accessories that, when combined with other components, are used to build external skeletal constructs for the devices intended use. The proposed device is a reprocessed version of the predicate device and the technological characteristics of these devices are substantially equivalent.
Performance Testing
The functional characteristics of the subject device have been evaluated and have been determined to be substantially equivalent to the predicate device based on the following tests: Functional performance studies:
o simulated use and artificial soiling; and o structural integrity;
o carbon rod stiffness per the 4-point bend test (pre-conditioning);
o cyclical axial compression and tension bending test; o carbon rod stiffness per the 4-point bend test (post
conditioning); and o disassembly and reassembly (pre-and post-sterilization).
Cleaning: o visual inspection; o cleaning efficacy (residual protein and residual carbohydrate).
Device Models
OEM Model
Description
Hoffmann II
4920-1-010 Rod to Rod Coupling for 8mm rods or posts 4920-1-020 Pin to Rod Coupling for 4-5mm pins/8mm rods or posts
4920-1-030 Inverted Pin to Rod Coupling for 8mm rods or posts/4-5mm pins
4920-1-100 Tube to Rod Coupling for 20mm tubes/8mm rods or posts 4920-2-020 5 Hole Pin Clamp for 4/5/6mm pins 4920-2-060 10-Hole Pin Clamp for 4/5/6mm pins 4920-2-080 Pelvic Clamp for 4/5/6mm pins 4920-2-120 Straight Post 8mm 4920-2-140 30° Angled Post 8mm 4920-2-160 90° Angled Post 8mm
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Device Models continued
OEM Model
Description
Hoffman II continued 4920-2-181 HII THREADED POST W 13mm NUT 4920-9-020 Removable Thumbwheel 4940-1-010 Rod to Rod Coupling for Ø5mm rods or posts 4940-1-015 HII Compact Baltimore Coupling 4940-1-020 Pin to Rod Coupling- Ø5mm rods or posts/Ø3-4mm pins 4940-1-058 Rod to Rod Coupling-Ø8mm rods, posts/Ø5mm rods, posts 4940-1-100 Tube to Rod Coupling - Ø15mm tube/Ø5mm rods or posts
4940-2-020 Hoffmann 2 Compact Pin Clamp 4 hole Pin Clamp-Ø3 and Ø4mm pins
4940-2-120 Straight Post Ø5mm 4940-2-140 30° Angled Post Ø5mm 4940-2-200 Peri-Articular Pin Clamp for Ø3mm pins 4960-1-010 Micro Rod to Rod Coupling 3mm/3mm 4960-1-020 Micro Pin to Rod Coupling 1.65mm-2mm/3mm 4960-1-060 Micro Rod to Rod Coupling 5mm/3mm 4960-2-020 Micro Multi-Pin Clamp 4960-2-030 90° Micro Multi-Pin Clamp 4960-3-020 HII Micro Lengthener Pin Clamp 4960-3-030 HII Micro Lengthener Thumbwheel 5029-1-611 Ball Joint 5 Hole Double Parallel 5029-8-805 Carbon Connecting Rod 8mm x 65mm 5029-8-810 Carbon Connecting Rod 8mm x 100mm 5029-8-815 Carbon Connecting Rod 8mm x 150mm 5029-8-820 Carbon Connecting Rod 8mm x 200mm 5029-8-825 Carbon Connecting Rod 8mm x 250mm 5029-8-830 Carbon Connecting Rod 8mm x 300mm 5029-8-835 Carbon Connecting Rod 8mm x 350mm 5029-8-840 Carbon Connecting Rod 8mm x 400mm 5029-8-845 Carbon Connecting Rod 8mm x 450mm 5029-8-850 Carbon Connecting Rod 8mm x 500mm 5049-5-065 Stainless Steel Connecting Rod Ø5mm x 65mm 5049-5-100 Stainless Steel Connecting Rod Ø5mm x 100mm 5049-5-150 Stainless Steel Connecting Rod Ø5mm x 150mm 5049-5-200 Stainless Steel Connecting Rod Ø5mm x 200mm 5049-5-250 Stainless Steel Connecting Rod Ø5mm x 250mm 5049-5-300 Stainless Steel Connecting Rod Ø5mm x 300mm 5049-5-505 Carbon Connecting Rod Ø5mm x 65mm 5049-5-510 Carbon Connecting Rod Ø5mm x 100mm 5049-5-515 Carbon Connecting Rod Ø5mm x 150mm 5049-5-520 Carbon Connecting Rod Ø5mm x 200mm 5049-5-525 Carbon Connecting Rod Ø5mm x 250mm 5049-5-530 Carbon Connecting Rod Ø5mm x 300mm 5049-7-018 Semi Circular Curved Rod-Stainless Steel Ø5mm x 111mm 5049-7-020 Semi Circular Curved Rod-Stainless Steel Ø5mm x 146mm
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OEM Model Description
Hoffman II continued 5079-5-030 Stainless Steel Connecting Rod 3mm x 30mm 5079-5-040 Stainless Steel Connecting Rod 3mm x 40mm 5079-5-050 Stainless Steel Connecting Rod 3mm x 50mm 5079-5-060 Stainless Steel Connecting Rod 3mm x 600mm 5079-5-070 Connecting Rod 3mm x 70mm 5079-5-090 Stainless Steel Connecting Rod 3mm x 90mm 5079-5-120 Stainless Steel Connecting Rod 3mm x 120mm 5079-5-150 Stainless Steel Connecting Rod 3mm x 150mm 5079-5-180 Connecting Rod 3mm x 180mm 5079-5-250 Connecting Rod 3mm x 250mm 5079-5-300 Connecting Rod 3mm x 300mm 5079-6-030 Carbon Connecting Rod 3mm x 30mm 5079-6-040 Carbon Connecting Rod 3mm x 40mm 5079-6-050 Carbon Connecting Rod 3mm x 50mm 5079-6-060 Carbon Connecting Rod 3mm x 60mm 5079-6-090 Carbon Connecting Rod 3mm x 90mm 5079-6-120 Carbon Connecting Rod 3mm x 120mm 5079-6-150 Carbon Connecting Rod 3mm x 150mm Hoffmann II MR Conditional (3.0 T)
4921-1-010 MR conditional 8mm Rods or Posts, Rod to Rod Coupling (Gold Hardware)
4921-1-020 MR conditional Pin to Rod Coupling for Ø4-5mm pins/Ø8mm rods or posts (Gold Hardware)
4921-1-030 MR conditional Inverted Pin to Rod Coupling for Ø8mm rods or posts/Ø4-5mm pins (Gold Hardware)
4921-1-100 MR conditional Tube to Rod Coupling for Ø20mm tubes/Ø8mm rods or posts (Gold Hardware)
4921-2-020 MR conditional 5-Hole Pin Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware)
4921-2-060 MR conditional 10-Hole Pin Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware)
4921-2-080 MR conditional Pelvic Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware)
4921-2-120 MR conditional Straight Post Ø8mm (Gold Tip) 4921-2-140 MR conditional 30° Angled Post Ø8mm (Gold Tip)
4941-1-010 MR conditional rod to Rod Coupling for Ø5mm rods or posts
4941-1-020 MR conditional Pin to Rod Coupling for Ø5mm rods or posts/Ø3-4mm pins
4941-1-058 MR conditional Rod to Rod Coupling for Ø8mm rods or posts/Ø5mm rods or posts
4941-1-100 MR conditional Tube to Rod Coupling for Ø15mm tube/Ø5mm rods or posts
4941-2-120 MR conditional 30° Angled Post Ø5mm 4941-2-140 MR conditional 4941-2-140 30° Angled Post Ø5mm 4941-2-200 MR conditional Peri-Articular Pin Clamp for Ø3mm pins
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OEM Model Description
Hoffmann II MR Conditional (3.0 T) 5028-7-030 MR conditional Semi-Circular Carbon Rod 174mm (L)
5028-8-065 MR conditional Carbon Connecting Rod 65mm Ø8mm (Yellow)
5028-8-100 MR conditional Carbon Connecting Rod 100mm Ø8mm (Yellow)
5028-8-150 MR conditional Carbon Connecting Rod 150mm Ø8mm (Yellow)
5028-8-200 MR conditional Carbon Connecting Rod 200mm Ø8mm (Yellow)
5028-8-250 MR conditional Carbon Connecting Rod 250mm Ø8mm (Yellow)
5028-8-300 MR conditional Carbon Connecting Rod 300mm Ø8mm (Yellow)
5028-8-350 MR conditional Carbon Connecting Rod 350mm Ø8mm (Yellow)
5028-8-400 MR conditional Carbon Connecting Rod 400mm Ø8mm (Yellow)
5028-8-450 MR conditional Carbon Connecting Rod 450mm Ø8mm (Yellow)
5028-8-500 MR conditional Carbon Connecting Rod 500mm Ø8mm (Yellow)
5048-5-065 MR conditional Carbon Connecting Rod 65mm Ø5mm (Yellow)
5048-5-100 MR conditional Carbon Connecting Rod 100mm Ø5mm (Yellow)
5048-5-150 MR conditional Carbon Connecting Rod 150mm Ø5mm (Yellow)
5048-5-200 MR conditional Carbon Connecting Rod 200mm Ø5mm (Yellow)
5048-5-250 MR conditional Carbon Connecting Rod 250mm Ø5mm (Yellow)
5048-5-300 MR conditional Carbon Connecting Rod 300mm Ø5mm (Yellow)
4921-2-020AHS MR conditional 5 HOLE PIN CLAMP
4921-2-160 MR conditional 90 DEGREE POST 4941-2-020 4 hole pin clamp for Ø3 and Ø4mm pins Hoffman 3 MR conditional (1.5 T)
4922-1-010 Delta Coupling, Rod-to-Rod or Pin-to-Rod, Ø5/8/11mm Rods and Ø5mm Apex Pins
4922-1-020 Delta Coupling, Pin-to-Rod, Ø5/8/11mm Rods and Ø4/5/6mm Apex Pins
4922-1-030 Delta Coupling, Pin-to-Rod, inverted, Ø5/8/11mm Rods and Ø4/5/6mm Apex Pins
4922-2-020 5-Hole Pin Clamp 4922-2-120 Straight Post Ø11mm
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OEM Model Description
Hoffman III MR conditional (1.5 T) 4922-2-140 30° Angled Post Ø11mm 4922-2-160 90° Angled Post Ø11mm 4922-2-220 5-Hole Pin Clamp with two Ø11mm Straight Posts 4922-2-240 5-Hole Pin Clamp with two Ø11mm 30o Angled Posts 4922-2-320 5-Hole Pin Clamp with one Ø11mm Straight Post 4922-2-340 5-Hole Pin Clamp with one Ø11mm 30o Angled Post 4922-8-100 Ø11mm Vectran coated Carbon Connecting Rods 100mm 4922-8-150 Ø11mm Vectran coated Carbon Connecting Rods 150mm 4922-8-200 Ø11mm Vectran coated Carbon Connecting Rods 200mm 4922-8-250 Ø11mm Vectran coated Carbon Connecting Rods 250mm 4922-8-300 Ø11mm Vectran coated Carbon Connecting Rods 300mm 4922-8-350 Ø11mm Vectran coated Carbon Connecting Rods 350mm 4922-8-400 Ø11mm Vectran coated Carbon Connecting Rods 400mm 4922-8-450 Ø11mm Vectran coated Carbon Connecting Rods 450mm 4922-8-500 Ø11mm Vectran coated Carbon Connecting Rods 500mm 4922-8-550 Ø11mm Vectran coated Carbon Connecting Rods 550mm 4922-8-600 Ø11mm Vectran coated Carbon Connecting Rods 600mm 4922-8-650 Ø11mm Vectran coated Carbon Connecting Rods 650mm a OEM = original equipment manufacturer.
Conclusion
Based on a comparison of the indications for use, intended use, technological characteristics, and performance data to the predicate device, Medline ReNewal Reprocessed Stryker External Fixation Devices are substantially equivalent to the predicate device.
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