510(k) K002757 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
ONCOLOGY SALVAGE SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 24, 2000 |
| Received | Sep 5, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002757
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage. Terminated |
JDI | None listed |
| Apr 17, 2020 | Biomet, Inc. Knee Products:
150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis Terminated |
JDI | None listed |
| Oct 10, 2018 | Zimmer Biomet, Inc. Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394 Terminated |
KRO | None listed |
| Jun 5, 2017 | Zimmer Biomet, Inc. OSS CEMENTED IM STEM 12X150, model # 150366 Terminated |
JDI | None listed |
| Jan 11, 2012 | Biomet, Inc. OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY.
Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications. Terminated |
KRO | None listed |
| Jun 29, 2009 | Biomet, Inc. Biomet OSS FINN Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472086.
A non-powered, orthopedic manual surgical instrument for use with ot Terminated |
KRO | None listed |
| Jun 29, 2009 | Biomet, Inc. Biomet OSS FINN Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472087.
A non-powered, orthopedic manual surgical instrument for use with oth Terminated |
KRO | None listed |
| Jun 29, 2009 | Biomet, Inc. Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472088.
A non-powered, orthopedic manual surgical instrument for use with Terminated |
KRO | None listed |
| Jun 29, 2009 | Biomet, Inc. Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472089.
A non-powered, orthopedic manual surgical instrument for use with o Terminated |
KRO | None listed |
| Jun 29, 2009 | Biomet, Inc. Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472124.
A non-powered, orthopedic manual surgical instrument for us Terminated |
KRO | None listed |
| Jun 29, 2009 | Biomet, Inc. Biomet OSS Elliptical Proximal Femoral Trial 7 cm left provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472125.
A non-powered, orthopedic manual surgical instrument for use Terminated |
KRO | None listed |
| Sep 11, 2008 | Biomet, Inc. Biomet OSS Interlok IM Stem w/Screw, straight collar, 11 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150490. Orthopedic implant intended as part of a replacement kn Terminated |
KRO | None listed |
| Sep 11, 2008 | Biomet, Inc. Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150491. Orthopedic implant intended as part of a replacement kn Terminated |
KRO | None listed |
| Sep 11, 2008 | Biomet, Inc. Biomet OSS Interlok IM Stem w/Screw, straight collar, 15 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150492. Orthopedic implant intended as part of a replacement kn Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.