ClearanceBrief
510(k) K023211 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS

ApplicantZimmer, Inc., Warsaw IN, US
DecisionSubstantially Equivalent, Oct 17, 2002
ReceivedSep 26, 2002
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K023211

DateFirm and productCodeLinked 510(k)
Nov 29, 2017Zimmer Biomet, Inc.
CR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT FEM E-L MINUS CR-FLEX OPT FEM E-R MINUS CR-FLEX OPT FEM F-L MINUS CR-FLEX OPT FEM F-R MINUS CR-FLEX OPT FEM G-
Terminated		 JWHNone listed
Nov 29, 2017Zimmer Biomet, Inc.
CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM E-L CR-FLEX OPT FEM E-R CR-FLEX OPT FEM F-L CR-FLEX OPT FEM F-R CR-FLEX OPT FEM G-L CR-FLEX OPT FEM G-R
Terminated		 JWHNone listed
Nov 29, 2017Zimmer Biomet, Inc.
CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disability
Terminated		 MBHNone listed
Nov 29, 2017Zimmer Biomet, Inc.
CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L MINUS CR-FLEX PCT FEM E-R MINUS CR-FLEX PCT FEM F-L MINUS CR-FLEX PCT FEM F-R MINUS CR-FLEX PCT FEM G-
Terminated		 JWHNone listed
Nov 29, 2017Zimmer Biomet, Inc.
CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX PCT FEM D-R CR-FLEX PCT FEM E-L CR-FLEX PCT FEM E-R CR-FLEX PCT FEM F-L CR-FLEX PCT FEM F-R CR-FLEX PCT FEM G-L
Terminated		 JWHNone listed
Feb 22, 2016Zimmer Biomet, Inc.
NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is
Terminated		 JWHNone listed

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