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510(k) K060370 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS

Applicant	Zimmer, Inc., Warsaw IN, US
Decision	Substantially Equivalent, Apr 28, 2006
Received	Feb 13, 2006
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K060370

Date	Firm and product	Code	Linked 510(k)
Nov 29, 2017	Zimmer Biomet, Inc. LPS-FLEX GSF OPT SZ C-L LPS-FLEX GSF OPT SZ C-R LPS-FLEX GSF OPT SZ D-L LPS-FLEX GSF OPT SZ D-R LPS-FLEX GSF OPT SZ E-L LPS-FLEX GSF OPT SZ E-R LPS-FLEX GSK OPT SZ F-L LPS-FLEX GSF OPT SZ F-R LPS-FLEX Terminated	JWH	None listed
Nov 29, 2017	Zimmer Biomet, Inc. CR-FLEX GSF PCT SZ C-R MINUS CR-FLEX GSF PCT SZ D-L MINUS CR-FLEX GSF PCT SZ D-R MINUS CR-FLEX GSF PCT SZ E-L MINUS CR-FLEX GSF PCT SZ E-R MINUS CR-FLEX GSF PCT SZ F-L MINUS CR-FLEX GSF PCT SZ F-R MIN Terminated	JWH	None listed
Nov 29, 2017	Zimmer Biomet, Inc. CR-FLEX GSF PRECOAT SZ C-L CR-FLEX GSF PRECOAT SZ C-R CR-FLEX GSF PRECOAT SZ D-L CR-FLEX GSF PRECOAT SZ D-R CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R CR-FLEX GSF PRECOAT SZ F-L CR-FLEX GSF Terminated	JWH	None listed
Feb 22, 2016	Zimmer Biomet, Inc. LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes Product Usage "" This device is indicated for patients with severe knee pain an Terminated	JWH	None listed
Oct 25, 2013	Zimmer, Inc. NexGen Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R Terminated	JWH	None listed
Oct 25, 2013	Zimmer, Inc. NexGen Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF POR FEM, D-R CR-FLE Terminated	JWH	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
Mar 2, 2010	Zimmer Inc. NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN. Terminated	JWH	None listed
Dec 14, 2009	Zimmer Inc. Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-57 Terminated	JWH	None listed

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