510(k) K022555 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
ACCOLADE C FEMORAL STEMS
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Aug 26, 2002 |
| Received | Aug 2, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2010 | Stryker Howmedica Osteonics Corp. Accolade System Surgical Technique;
Accolade C - Cemented Hip Stem;
Accolade TMZF Cementless Hip System;
Accolade HFx Cementless Hip System.
Stryker Orthopaedics.
Surgical protocols instruct surgeons Terminated |
LZO | None listed |
| Jan 11, 2010 | Stryker Howmedica Osteonics Corp. CuttingEdge Total Hip Instrumentation Surgical Protocol;
Acetabular and Femoral Surgical Technique for Primary Press Fit and Cemented Hip Implants.
Stryker Howmedica Osteonics.
Surgical protocols ins Terminated |
LZO | None listed |
| Jan 11, 2010 | Stryker Howmedica Osteonics Corp. OmniFit Eon 127 degree and 132 degree Surgical Protocol;
Stryker.
Surgical protocols instruct surgeons on proper surgical technique. Terminated |
LZO | None listed |
| Jan 11, 2010 | Stryker Howmedica Osteonics Corp. OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive, Mahwah, NJ 07430.
Surgical protocols instruct surgeons on proper surgical technique. Terminated |
LZO | None listed |
| Jan 11, 2010 | Stryker Howmedica Osteonics Corp. Secur-Fit MAX Secure-FIT Plus Max Surgical Protocol.
Surgical protocols instruct surgeons on proper surgical technique. Terminated |
LZO | None listed |
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Accolade C CS
These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthr Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.