| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Total Knee System, ATTUNET |
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| Generic Name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
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| Applicant | Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw, IN 46581 |
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| PMA Number | P830055 |
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| Supplement Number | S325 |
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| Date Received | 06/28/2024 |
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| Decision Date | 03/13/2025 |
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| Product Code |
NJL |
| Advisory Committee |
Orthopedic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for the addition of ATTUNETM Porous Medialized Dome and Anatomic Patella with AFFIXIUMTM 3DP Technology as compatible devices to the ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Total Knee System, and ATTUNETM Revision Rotating Platform (RP) Total Knee System, and the following four associated manufacturing facilities:Paragon Medical, Inc.8 Matchett DrPierceton, Indiana 46562Role performed: Machining3D Systems, Inc.5381 South Alkire CircleLittleton, Colorado 80127Role performed: Additive manufacturing (3D Printing)Millstone Medical Outsourcing LLC580 Commerce DriveFall River, Massachusetts 02720Role performed: Final cleaning and packagingRestoration Medical Polymers4474 E Park 30 DriveColumbia City, Indiana 46725Role performed: Overmolding for the patella components |
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