510(k) K052917 ยท NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
STRYKER COMPARTMENTAL KNEE SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Dec 27, 2005 |
| Received | Oct 17, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052917
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. SCORPIO C-DOME PATELLA
73-2710
73-2910
SCORPIO U-DOME PATELLA
73-3110
73-3508
73-3708
73-3710
73-3910
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
NPJ | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3110 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3308 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3508 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3708 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3710 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement
Part Number: 82-2-0910 Open, Classified |
JWH | None listed |
| Jan 11, 2012 | Stryker Howmedica Osteonics Corp. Eius Unicompartmental Knee System
Stryker Howmedica Osteonics Corp.
Howmedica International S. de R.L., Raheen Business Park, Limerick, Ireland.
Intended for use in Unicompartmental Knee Arthroplasty Terminated |
NPJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.