510(k) K872379 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
INSALL/BURSTEIN* II MODULAR TOTAL KNEE
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 28, 1987 |
| Received | Jun 19, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872379
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2022 | Zimmer, Inc. NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 Open, Classified |
JWH | None listed |
| Dec 9, 2022 | Zimmer, Inc. NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02 Open, Classified |
JWH | None listed |
| Dec 9, 2022 | Zimmer, Inc. NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01 Open, Classified |
JWH | None listed |
| Dec 9, 2022 | Zimmer, Inc. NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02 Open, Classified |
JWH | None listed |
| Dec 9, 2022 | Zimmer, Inc. NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01 Open, Classified |
JWH | None listed |
| Dec 9, 2022 | Zimmer, Inc. NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02 Open, Classified |
JWH | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 35 consists of all product under product code: JWH and same usage:
Item no:
522007300 I/B II KNEE FLUTED ROD, 1
for use in total knee arthroplasty Terminated |
JWH | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 51 consists of all product under product code: JWH and same usage:
Item no:
598603701 NEXGEN OPTION STEMMED TIB
598603702 NEXGEN OPTION STEMMED TIB
598604701 NEXGEN OPTION STEMMED TIB
598604 Terminated |
JWH | None listed |
| Feb 20, 2014 | Zimmer, Inc. I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST Terminated |
JWH | None listed |
| Feb 20, 2014 | Zimmer, Inc. MODULAR CUP NEUTRAL LINER
MODULAR CUP 10 DEGREE LIN
MODULAR CUP 20 DEGREE LIN
MODULAR CUP 7MM OFFSET LI Terminated |
LPH | None listed |
| Nov 26, 2012 | Zimmer, Inc. NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component
The NexGen system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.