510(k) K133940 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
| Applicant | Biomet UK, Ltd., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 28, 2014 |
| Received | Dec 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133940
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2023 | Biomet, Inc. Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component
Item Number: 154341 Open, Classified |
HRY | None listed |
| Dec 17, 2020 | Biomet, Inc. Oxford Fixed Lateral, Item numbers 154330, 154370, 154373
154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement. Terminated |
HRY | None listed |
| Apr 17, 2020 | Biomet, Inc. Knee Products:
154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3
154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4
154339 Oxford Terminated |
HRY | None listed |
| Jan 6, 2017 | Zimmer Biomet, Inc. Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum seale Terminated |
HRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.