ClearanceBrief
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

ApplicantZimmer, Inc., Warsaw IN, US
DecisionSubstantially Equivalent, Apr 26, 1996
ReceivedJan 19, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K960279

DateFirm and productCodeLinked 510(k)
Jan 28, 2025Zimmer, Inc.
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Open, Classified
JWHNone listed
Jan 28, 2025Zimmer, Inc.
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Open, Classified
JWHNone listed
Nov 29, 2017Zimmer Biomet, Inc.
LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability
Terminated
JWHNone listed
Nov 29, 2017Zimmer 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
NJLNone listed
Nov 29, 2017Zimmer 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
NJLNone listed
Nov 29, 2017Zimmer 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
JWHNone listed
Nov 29, 2017Zimmer 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
NJLNone listed
Mar 12, 2016Zimmer 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
JWHNone listed
Feb 22, 2016Zimmer 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
JWHNone listed
May 1, 2015Zimmer, 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
JWHNone listed
Feb 20, 2014Zimmer, Inc.
MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI
Terminated
LPHNone listed
Dec 13, 2010Zimmer Inc.
NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.
Terminated
LXHNone listed
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Left, sterile, REF 00-5996-017-01.
Terminated
JWHNone listed
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Right, sterile, REF 00-5996-017-02.
Terminated
JWHNone listed
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Left, sterile, REF 00-5996-016-01.
Terminated
JWHNone listed
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Right, sterile, REF 00-5996-016-02.
Terminated
JWHNone listed
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size E Right, sterile, REF 00-5996-015-02.
Terminated
JWHNone listed
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size G Left, sterile, REF 00-5764-017-51.
Terminated
JWHNone listed
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size F Right, sterile, REF 00-5764-016-52.
Terminated
JWHNone listed
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Left, sterile, REF 00-5764-015-51.
Terminated
JWHNone listed
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Right, sterile, REF 00-5764-015-52.
Terminated
JWHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.