510(k) K033972 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
SCORPIO TOTAL KNEE SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Apr 12, 2004 |
| Received | Dec 22, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033972
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. SCORPIO RECESSED METAL BACKED PATELLA
3045-0026
3045-0028
3045-0030
3045-0032
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
MBH | None listed |
| Sep 13, 2016 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10)
The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for th Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.