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)
Feb 5, 2021Encore Medical, LP
DJO EMPOWR KNEE Femoral Sizer
Open, Classified		 JWHK143242
Jan 8, 2021DePuy Orthopaedics, Inc.
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Terminated		 JWHK063633
Dec 1, 2020Biomet, Inc.
Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
Terminated		 JWHK093293
Sep 21, 2020Smith & Nephew, Inc.
Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral a
Terminated		 JWHK962137
Aug 8, 2020Smith & Nephew, Inc.
Tibial knee prosthesis
Open, Classified		 JWHK951987
Jul 20, 2020Conformis, Inc.
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Terminated		 JWHK180906
Apr 17, 2020Biomet, Inc.
Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis
Terminated		 JWHK040770
Apr 17, 2020Biomet, Inc.
Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS
Terminated		 JWHK023546
Apr 17, 2020Biomet, Inc.
Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock
Terminated		 JWHK060525
Apr 17, 2020Biomet, Inc.
Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono
Terminated		 JWHK060525
Apr 17, 2020Biomet, Inc.
Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 6
Terminated		 JWHK023546
Apr 17, 2020Biomet, Inc.
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibi
Terminated		 JWHK921182
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
Terminated		 JWHK050210
K161273
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
Terminated		 JWHK050210
K161273
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
Terminated		 JWHK050210
K161273
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
Terminated		 JWHK050210
K161273
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
Terminated		 JWHK050210
K161273
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
Terminated		 JWHK050210
K161273
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
Terminated		 JWHK050210
K161273
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
Terminated		 JWHK050210
K161273
Feb 3, 2020Conformis, Inc.
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacemen
Terminated		 JWHK161668
Feb 3, 2020Conformis, Inc.
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee repla
Terminated		 JWHK180906
Jan 27, 2020Exactech, Inc.
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and
Open, Classified		 JWHK150890
Jan 21, 2020Aesculap Implant Systems LLC
COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z
Terminated		 JWHK083772
Jan 21, 2020Aesculap Implant Systems LLC
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z
Terminated		 JWHK071220
Jan 21, 2020Aesculap Implant Systems LLC
COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K Product Usage: Tibia-Plateaus are pa
Terminated		 JWHK053390
Jan 21, 2020Aesculap Implant Systems LLC
COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088K NN089K Product Usage: Tibia-Plateaus are part of implants
Terminated		 JWHK030367
Jan 21, 2020Aesculap Implant Systems LLC
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K Product Usage:Tibia-Plateaus are par
Terminated		 JWHK022672
Dec 19, 2019Smith & Nephew, Inc.
LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Terminated		 JWHK071071
Oct 25, 2019Conformis, Inc.
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint p
Terminated		 JWHK180906
Oct 10, 2019Zimmer Biomet, Inc.
Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 32855430502
Terminated		 JWHK120990
Oct 10, 2019Zimmer Biomet, Inc.
Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 00522007000 005
Terminated		 JWHK173057
Aug 15, 2019Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 87 mm Item # 195254
Terminated		 JWHK122160
Aug 15, 2019Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 83 mm Item # 195253
Terminated		 JWHK122160
Aug 15, 2019Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 79 mm Item # 195252
Terminated		 JWHK122160
Aug 15, 2019Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 75 mm Item # 195251
Terminated		 JWHK122160
Aug 15, 2019Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 73 mm Item # 195250
Terminated		 JWHK122160
Aug 15, 2019Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 71 mm Item # 195249
Terminated		 JWHK122160
Aug 15, 2019Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 69 mm Item # 195248
Terminated		 JWHK122160
Aug 15, 2019Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 67 mm Item # 195247
Terminated		 JWHK122160
Aug 15, 2019Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 65 mm Item # 195246
Terminated		 JWHK122160
Aug 15, 2019Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 63 mm Item # 195245
Terminated		 JWHK122160
Aug 15, 2019Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 59 mm Item # 195750
Terminated		 JWHK153657
Aug 15, 2019Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 63 mm Item # 195751
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 65 mm Item # 195752
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 67 mm Item # 195753
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 71 mm Item # 195755
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 73 mm Item # 195756
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 75 mm Item # 195757
Terminated		 JWHK132873

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