510(k) K960279 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 26, 1996 |
| Received | Jan 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960279
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2025 | Zimmer, Inc. NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14 Open, Classified |
JWH | None listed |
| Jan 28, 2025 | Zimmer, Inc. NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10 Open, Classified |
JWH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. LPS FEM IMPLANT SZ H-R
This device is indicated for patients with severe knee pain and disability Terminated |
JWH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. LPS OPTION FEMORAL C-L
LPS OPTION FEMORAL C-R
LPS OPTION FEMORAL D-L
LPS OPTION FEMORAL D-R
LPS OPTION FEMORAL E-L
LPS OPTION FEMORAL E-R
LPS OPTION FEMORAL F-L
LPS OPTION FEMORAL F-R
LPS OPTION FEMOR Terminated |
NJL | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. LPS FEM COMP SZ B-L
LPS FEM COMP SZ B-R
LPS FEM COMP SZ C-L
LPS FEM COMP SZ C-R
LPS FEM COMP SZ D-L
LPS FEM COMP SZ D-R
LPS FEM COMP SZ E-L
LPS FEM COMP SZ E-R
LPS FEM COMP SZ F-L
LPS FEM COMP SZ F-R
Terminated |
NJL | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. LCCK FEM IMPLANT SZ C-L
LCCK FEM IMPLANT SZ C-R
LCCK FEM IMPLANT SZ D-R
LCCK FEM IMPLANT SZ E-L
LCCK FEM IMPLANT SZ E-R
LCCK FEM IMPLANT SZ F-L
LCCK FEM IMPLANT SZ F-R
This device is indicated for pa Terminated |
JWH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. LPS PRECOAT FEM SIZE D-RT
LPS PRECOAT FEM SIZE E-RT
LPS POROUS FEM SIZE F-RT
This device is indicated for patients with severe knee pain and disability Terminated |
NJL | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 48 consists of all product under product code: JWH and same usage:
Item no:
597206526 NEXGEN ALL-POLY PATELLA,
for use in total knee arthroplasty Terminated |
JWH | None listed |
| Feb 22, 2016 | Zimmer Biomet, Inc. NexGen Knee LPS Porous FEM
NexGen Knee LPS Option FEM
NexGen Knee Lock FEM
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
various sizes
Product Usage "" This Terminated |
JWH | None listed |
| May 1, 2015 | Zimmer, Inc. NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10.
Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur. 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 |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Left, sterile, REF 00-5996-017-01. Terminated |
JWH | None listed |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Right, sterile, REF 00-5996-017-02. Terminated |
JWH | None listed |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Left, sterile, REF 00-5996-016-01. Terminated |
JWH | None listed |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Right, sterile, REF 00-5996-016-02. Terminated |
JWH | None listed |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size E Right, sterile, REF 00-5996-015-02. Terminated |
JWH | None listed |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size G Left, sterile, REF 00-5764-017-51. Terminated |
JWH | None listed |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size F Right, sterile, REF 00-5764-016-52. Terminated |
JWH | None listed |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Left, sterile, REF 00-5764-015-51. Terminated |
JWH | None listed |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Right, sterile, REF 00-5764-015-52. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.