ClearanceBrief
Panels › Orthopedic › Product code JWH · Class 2

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Regulation 888.3560

14510(k)s in 12 months (921 all time)
7recalls in 12 months (985 all time)
888recalls that name a 510(k)
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Top companies in JWH

Company510(k)sRecalls
Zimmer, Inc.51304
DePuy Orthopaedics, Inc.16102
Smith & Nephew, Inc.4960
Exactech, Inc.3264
Howmedica Osteonics3261
Zimmer Biomet, Inc.085
Biomet, Inc.4044
Stryker Howmedica Osteonics064
Conformis, Inc.4019
Encore Medical L.P.1544
DateFirm and productCodeLinked 510(k)
Mar 30, 2018Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligamen
Terminated		 JWHK071071
Mar 30, 2018Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligame
Terminated		 JWHK071071
Mar 30, 2018Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligam
Terminated		 JWHK071071
Mar 30, 2018Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligam
Terminated		 JWHK071071
Jan 15, 2018Smith & Nephew, Inc.
LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, whe
Completed		 JWHK043440
Dec 20, 2017Medacta Usa Inc
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF
Terminated		 JWHK090988
Dec 12, 2017Encore Medical, Lp
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
Terminated		 JWHK100900
Dec 12, 2017Encore Medical, Lp
EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
Terminated		 JWHK100900
Dec 12, 2017Encore Medical, Lp
EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
Terminated		 JWHK100900
Dec 12, 2017Encore Medical, Lp
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
Terminated		 JWHK100900
Nov 29, 2017Zimmer Biomet, Inc.
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 RT Compone
Terminated		 JWHK070214
K071107
Nov 29, 2017Zimmer 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		 JWHK060370
K071107
Nov 29, 2017Zimmer 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		 JWHK060370
K071107
Nov 29, 2017Zimmer 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		 JWHK060370
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		 JWHK023211
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		 JWHK023211
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		 JWHK023211
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		 JWHK023211
Nov 29, 2017Zimmer Biomet, Inc.
CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FEM COMP SIZE F/L CR O
Terminated		 JWHK911572
K933785
Nov 29, 2017Zimmer Biomet, Inc.
CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRECOAT FEM COMP SIZE H
Terminated		 JWHK031061
K911572 +1
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		 JWHK960279
Nov 29, 2017Zimmer Biomet, Inc.
LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability
Terminated		 JWHK960279
Nov 29, 2017Zimmer Biomet, Inc.
NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Structured Titanium (CSTi)
Terminated		 JWHK936159
Nov 29, 2017Zimmer Biomet, Inc.
CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Terminated		 JWHK960658
Nov 24, 2017United Orthopedic Corporation
U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee func
Terminated		 JWHK082424
Nov 24, 2017United Orthopedic Corporation
U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or i
Terminated		 JWHK051640
Nov 20, 2017OMNIlife science Inc.
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intende
Terminated		 JWHK060192
Sep 29, 2017Zimmer Biomet, Inc.
Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
Terminated		 JWHK023546
Sep 29, 2017Zimmer Biomet, Inc.
Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
Terminated		 JWHK023546
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.
Terminated		 JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.
Terminated		 JWHK023186

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