Panels › Orthopedic › Product code HSX · Class 2
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Regulation 888.3520
3510(k)s in 12 months (115 all time)
0recalls in 12 months (104 all time)
100recalls that name a 510(k)
Top companies in HSX
| Company | 510(k)s | Recalls |
|---|---|---|
| Smith & Nephew, Inc. | 13 | 54 |
| Linkbio Corp. | 0 | 32 |
| Conformis, Inc. | 8 | 3 |
| Zimmer, Inc. | 9 | 2 |
| Bodycad Laboratories, Inc. | 7 | 0 |
| Mako Surgical Corp. | 6 | 0 |
| Zimmer Biomet | 1 | 5 |
| Depuy, Inc. | 5 | 0 |
| Howmedica Corp. | 5 | 0 |
| Medacta International S.A. | 5 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2009 | Conformis Inc ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600010.
For cemented use only. System consists of femoral and tibial components. The femoral component is C Terminated |
HSX | K043570 K063432 +1 |
| Jun 17, 2006 | Smith & Nephew Inc Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 left, Part No. 71420136 Terminated |
HSX | None listed |
| Jun 17, 2006 | Smith & Nephew Inc Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 right, Part No. 71420152 Terminated |
HSX | None listed |
| Dec 14, 2004 | Smith & Nephew Inc Genesis Uni Articular Inserts Terminated |
HSX | K912735 |
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