510(k) K052990 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | Oct 24, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052990
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217. Terminated |
KWY | None listed |
| Sep 21, 2018 | Zimmer Biomet, Inc. StageOne Hip, Models 431207 & 431209Usage:
Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. T Terminated |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.