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)
Get daily alerts for JWHSample briefCSV

Top companies in JWH

DateFirm and productCodeLinked 510(k)
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
Terminated
JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.
Terminated
JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.
Terminated
JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
Terminated
JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.
Terminated
JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.
Terminated
JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
Terminated
JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
Terminated
JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.
Terminated
JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
Terminated
JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
Terminated
JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
Terminated
JWHK023186
Sep 19, 2017Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.
Terminated
JWHK023186
Sep 15, 2017Encore Medical, Lp
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with
Terminated
JWHK160342
Sep 15, 2017Encore Medical, Lp
EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused
Terminated
JWHK160342
Sep 14, 2017Smith & Nephew, Inc.
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-tra
Terminated
JWHK041106
Aug 25, 2017Zimmer Biomet, Inc.
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
Terminated
JWHK833921
Aug 25, 2017Zimmer Biomet, Inc.
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
Terminated
JWHK833921
Aug 7, 2017Zimmer Biomet, Inc.
Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.
Terminated
JWHK113369
Aug 7, 2017Zimmer Biomet, Inc.
Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
Terminated
JWHK113369
K122765
Aug 7, 2017Zimmer Biomet, Inc.
Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
Terminated
JWHK113369
Aug 7, 2017Zimmer Biomet, Inc.
Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
Terminated
JWHK113369
Aug 1, 2017Smith & Nephew, Inc.
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
Terminated
JWHK951987
Jul 24, 2017ConforMIS, Inc.
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients wi
Terminated
JWHK161668
Jun 19, 2017Exactech, Inc.
Exactech Optetrak Logic CC 15mm Tibial Augment Screws
Terminated
JWHK150890
Jun 12, 2017Smith & Nephew, Inc.
LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
Terminated
JWHK162775
Jun 12, 2017Smith & Nephew, Inc.
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Terminated
JWHK162775
May 31, 2017Encore Medical, Lp
3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused w
Terminated
JWHK091956
May 31, 2017Encore Medical, Lp
3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused
Terminated
JWHK091956
Apr 28, 2017Zimmer Biomet, Inc.
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Terminated
JWHK933785
Mar 27, 2017Zimmer Biomet, Inc.
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete
Terminated
JWHK040770
K042757 +1
Feb 20, 2017Medtronic Sofamor Danek USA Inc
Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Compon
Terminated
JWHK150496
Feb 20, 2017Medtronic Sofamor Danek USA Inc
Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 c) Poly Compon
Terminated
JWHK150496
Feb 20, 2017Medtronic Sofamor Danek USA Inc
Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 c) Poly Comp Trial
Terminated
JWHK150496
Feb 20, 2017Medtronic Sofamor Danek USA Inc
Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Pol
Terminated
JWHK150496
Feb 3, 2017Encore Medical, Lp
Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base
Terminated
JWHK160342
Jan 10, 2017ConforMIS, Inc.
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disab
Terminated
JWHK161668
Jan 4, 2017Zimmer Biomet, Inc.
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number
Terminated
JWHK023546
Dec 15, 2016Zimmer Biomet, Inc.
Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
Terminated
JWHK142933
Nov 15, 2016Encore Medical, Lp
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Terminated
JWHK143242
Oct 18, 2016ConforMIS, Inc.
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability wh
Terminated
JWHK160025
Oct 18, 2016Zimmer Biomet, Inc.
Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments ar
Terminated
JWHK023546
Oct 3, 2016Zimmer Biomet, Inc.
Vanguard 360 Revision Knee System Knee prostheses
Terminated
JWHK093293
Sep 19, 2016Encore Medical, Lp
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
Terminated
JWHK160342
Sep 19, 2016Encore Medical, Lp
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Terminated
JWHK160342
Jul 18, 2016Medtronic Sofamor Danek USA Inc
TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Terminated
JWHK150496
Jul 18, 2016Medtronic Sofamor Danek USA Inc
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Terminated
JWHK150496
Jul 18, 2016Medtronic Sofamor Danek USA Inc
TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
Terminated
JWHK150496
Jul 18, 2016Medtronic Sofamor Danek USA Inc
TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
Terminated
JWHK150496
Jul 18, 2016Medtronic Sofamor Danek USA Inc
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,
Terminated
JWHK150496

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.