510(k) K072619 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 21, 2007 |
| Received | Sep 17, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072619
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT
" These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibia Terminated |
MBH | None listed |
| Feb 22, 2016 | Zimmer Biomet, Inc. CR Flex GSF Porous Femoral
LPS Flex GSF Porous Femoral
LPS Flex Porous Femoral
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
various sizes Terminated |
MBH | 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.