510(k) K991581 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 30, 1999 |
| Received | May 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991581
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2017 | Zimmer Biomet, Inc. LPS-FLEX OPTION FEMORAL C-L
LPS-FLEX OPTION FEMORAL C-L
LPS-FLEX OPTION FEMORAL C-R
LPS-FLEX OPTION FEMORAL D-L
LPS-FLEX OPTION FEMORAL D-R
LPS-FLEX OPTION FEMORAL E-L
LPS-FLEX OPTION FEMORAL E-R
LPS- Terminated |
NJL | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. LPS-FLEX PRECOAT FEMORAL B-R
LPS-FLEX PRECOAT FEMORAL C-L
LPS-FLEX PRECOAT FEMORAL C-R
LPS-FLEX PRECOAT FEMORAL D-L
LPS-FLEX PRECOAT FEMORAL D-R
LPS-FLEX PRECOAT FEMORAL E-L
LPS-FLEX PRECOAT FEMORAL E Terminated |
NJL | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT
This device is indicated for patients with severe knee pain and disability Terminated |
NJL | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 54 consists of all product under product code: JWH and same usage:
Item no:
596009900 NEXGEN TAPER PLUG
for use in total knee arthroplasty Terminated |
JWH | None listed |
| Feb 22, 2016 | Zimmer Biomet, Inc. NexGen LPS-FLEX Option Femoral
NexGen LPS-FLEX Precoat Femoral
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
various sizes
Product Usage "" This device is in 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 |
| Dec 13, 2010 | Zimmer Inc. NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN. Terminated |
LXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.