| 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. |
| |
| Device | Attune Primary System |
|---|
| Generic Name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
|---|
| Applicant | Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw, IN 46581 |
|---|
| PMA Number | P830055 |
|---|
| Supplement Number | S334 |
|---|
| Date Received | 09/27/2024 |
|---|
| Decision Date | 02/20/2025 |
|---|
| Product Code |
NJL |
| Advisory Committee |
Orthopedic |
|---|
| Supplement Type | Normal 180 Day Track |
|---|
| Supplement Reason | Change Design/Components/Specifications/Material |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
Approval Order Statement
Approval for two changes: i) change in the manufacturing consolidation process of antioxidant (Pentaerythritol tetrakis [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate]) (AOX), Ultra-High Molecular Weight Polyethylene (UHMWPE) bar stock material for the Attune Cruciate Retaining Rotating Platform (CR RP) and the Attune Posterior Stabilized Rotating Platform (PS RP) tibial inserts components that belong to the Attune Primary System.ii) change in the sterilization process of the Attune Cruciate Retaining Rotating Platform (CR RP), Attune Posterior Stabilized Rotating Platform (PS RP) tibial inserts components and the Attune Medialized Anatomic and Medialized Dome Patellar Components that belong to the Attune Primary System 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 |
|
|
