510(k) K243817 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert
| Applicant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Feb 6, 2025 |
| Received | Dec 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243817
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. ALL POLY CONSTRAINED INSERT 54MM
69-2854
NRG KNEE CR
82-2-0512
82-2-0518
82-2-0912
NRG KNEE P/S
82-3-0318
SCORPIO + MOBILE BEARING PCS
78-5-0910
SCORPIO C-DOME PATELLA
73-2710
SC Open, Classified |
JWH | None listed |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.