Panels › Orthopedic › Product code OIY · Class 2
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Regulation 888.3560
1510(k)s in 12 months (12 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in OIY
| Company | 510(k)s | Recalls |
|---|---|---|
| Encore Medical L.P. | 4 | 3 |
| DePuy Orthopaedics, Inc. | 5 | 1 |
| Biomet Manufacturing Corp | 1 | 0 |
| Conformis, Inc. | 0 | 1 |
| Depuy Orthopedics, Inc. | 1 | 0 |
| Renovis Surgical Technologies, LLC | 1 | 0 |
| Zimmer, Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 22, 2026 | K252887 | DePuy ATTUNE Knee System DePuy Orthopaedics, Inc. | OIY |
| Nov 1, 2024 | K242665 | DePuy ATTUNE Total Knee System Depuy Orthopedics, Inc. | OIY |
| Jun 18, 2020 | K201347 | DePuy ATTUNE Total Knee System DePuy Orthopaedics, Inc. | OIY |
| Feb 14, 2013 | K120038 | A200 KNEE SYSTEM Renovis Surgical Technologies, LLC | OIY |
| Aug 15, 2012 | K121727 | MOVATION KNEE SYSTEM Encore Medical L.P. | OIY |
| Mar 14, 2012 | K113756 | HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA Encore Medical L.P. | OIY |
| Aug 30, 2011 | K111433 | DEPUY STTUNE (TM) PS KNEE SYSTEM DePuy Orthopaedics, Inc. | OIY |
| Mar 15, 2011 | K103756 | DEPUY ATTUNE TOTAL KNEE SYSTEM DePuy Orthopaedics, Inc. | OIY |
| Dec 21, 2010 | K103223 | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS Encore Medical L.P. | OIY |
| Dec 10, 2010 | K101433 | DEPUY ATTUNE KNEE SYSTEM DePuy Orthopaedics, Inc. | OIY |
| Sep 28, 2010 | K091956 | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 Encore Medical L.P. | OIY |
| Mar 9, 2010 | K100048 | E1 ANTIOXIDANT INFUSED TECHNOLOGY Biomet Manufacturing Corp | OIY |
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