510(k) K962152 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent for Some Indications, Aug 14, 1996 |
| Received | Jun 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962152
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement
Part Number: 73-0110 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement
Part Number: 73-0510 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement
Part Number: 73-0710 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement
Part Number: 73-0910 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement
Part Number: 73-2110 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement
Part Number: 73-2710 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement
Part Number: 73-2910 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 |
| Feb 19, 2010 | Stryker Howmedica Osteonics Corp. Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics.
Intended for cemented application to replace the articulating Terminated |
JWH | None listed |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio PS Femur Waffle Posts with LfIt;
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 |
| Sep 16, 2008 | Stryker Howmedica Osteonics Corp. Osteonics Scorpio Total Knee;
Posteriorly Stabilized Femoral Component; #13
with posts, low friction Ion treatment.
Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Terminated |
JWH | None listed |
| Sep 11, 2008 | Stryker Howmedica Osteonics Corp. Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Terminated |
KWY | None listed |
| Jul 16, 2008 | Stryker Howmedica Osteonics Corp. Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 71-4507R; Stryker Corp, Howmedic Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.