510(k) K030978 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
SCORPIO NRG KNEE SYSTEM
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Nov 20, 2003 |
| Received | Mar 28, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030978
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | Howmedica Osteonics Corp. Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement
Part Number: 82-2-0908 Open, Classified |
JWH | None listed |
| May 19, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Scorpio femoral component.
Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.
For use in total reconstructive replacement of the knee joint. Terminated |
JWH | None listed |
| Mar 16, 2010 | Stryker Howmedica Osteonics Corp. Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R.
Mahwah, NJ Terminated |
JWH | None listed |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Cruciate Retaining Femoral, Left/Right # 5;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total knee Terminated |
JWH | None listed |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Cruciate Retaining Femoral, Right # 7;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total knee arth Terminated |
JWH | None listed |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Cruciate Retaining Femoral, Left # 8;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total knee arthr Terminated |
JWH | None listed |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Posterior Stabilized Femoral, #3 Left;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total knee arth Terminated |
JWH | None listed |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Posterior Stabilized Femoral. # 4 left/right;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total kn Terminated |
JWH | None listed |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Posterior Stabilized Femoral, # 5 Left;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07340.
The Scorpio Femoral Components are a knee component that is utilized in total knee art Terminated |
JWH | None listed |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Posterior Stabilized Femoral, # 7 left/right;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total kn Terminated |
JWH | None listed |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Posterior Stabilized Femoral, #9 left;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total knee arth Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.