510(k) K974556 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Feb 27, 1998 |
| Received | Dec 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974556
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio CR Basic Femur with Posts;
Stryker Orthopaedics; 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). Terminated |
JWH | None listed |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio CR Waffle Femur Lfit with posts;
Stryker Orthopaedics;
325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty ( Terminated |
JWH | None listed |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio PS Basic Femur;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral Terminated |
JWH | None listed |
| Jul 16, 2008 | Stryker Howmedica Osteonics Corp. Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Terminated |
JWH | None listed |
| Oct 15, 2005 | Stryker Howmedica Osteonics Corp. Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package. Terminated |
JWH | None listed |
| Oct 15, 2005 | Stryker Howmedica Osteonics Corp. Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.