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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2023 | DePuy Orthopaedics, Inc. Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507 Open, Classified |
OIY | K111433 |
| Feb 13, 2023 | Conformis, Inc. iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE Open, Classified |
OIY | None listed |
| Oct 26, 2015 | Encore Medical, Lp Exprt Precision System: Revision Knee, Model Number 160-010-726/738
For use with the Exprt Knee System in total knee arthroplasty to replace the native patella. Terminated |
OIY | K140830 |
| Feb 4, 2015 | Zimmer, Inc. Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04.
Product Usage: The Persona TASPs are sterilizable instruments Inten Terminated |
OIY | K123459 |
| May 2, 2013 | Encore Medical, Lp 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System. Terminated |
OIY | K091956 |
| Aug 30, 2012 | Encore Medical, Lp 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm.
The insert is intended to more closely match the kinematics of the knee, allowing some rotation alon Terminated |
OIY | K091956 |
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