| 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 | Attune Revision Knee System |
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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 | S351 |
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| Date Received | 09/26/2025 |
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| Decision Date | 09/21/2026 |
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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 following two changes for the Attune Revision CRS Rotating Platform (CRS RP) tibial insert components of the Attune Revision Knee System:i. change in the manufacturing consolidation process to add ram extrusion as an alternative to compression molding for bar stock material antioxidant (Pentaerythritol tetrakis [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate]) (AOX), Ultra-High Molecular Weight Polyethylene (UHMWPE) material of the aforementioned components.ii. change in sterilization dose from a single, high dose sterilization to a split-dose sterilization method through a combination of crosslinking AOX UHMWPE raw material and final terminal sterilization of the aforementioned components. |
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