510(k) K833991 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
BIPOLAR HIP DEVICE
| Applicant | Zimmer, Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 30, 1984 |
| Received | Nov 21, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833991
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2017 | Zimmer Biomet, Inc. BIPOLAR METAL SHELL 48 MM OD
Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement Terminated |
KWY | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 16 consists of all product under poduct code: KWY and same usage:
Item no:
500103822 BIPOLAR LINER 38MM OD X 2
500103922 BIPOLAR LINER 39MM OD X 2
500104022 BIPOLAR LINER 40/41MM OD
50010402 Terminated |
KWY | None listed |
| Feb 22, 2016 | Zimmer Biomet, Inc. Bipolar Shell
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
various sizes
Use of the MultiPolar Bipolar Cup is indicated in: Fracture dislocation of th Terminated |
KWY | None listed |
| Feb 20, 2014 | Zimmer, Inc. Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD Terminated |
KWY | None listed |
| Oct 25, 2013 | Zimmer, Inc. Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD.
Indicated in fracture dislocation of the hip. Terminated |
KWY | None listed |
| Nov 20, 2012 | Zimmer, Inc. Multipolar Bipolar Cup Liner 22 mm LD.;
Item 00-5001-040-22
Product Usage:
The liner snaps into the Multipolar Bipolar Cup and serves as the articulation surface for the femoral head. The split poly Terminated |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.