ClearanceBrief
Product code NJL ยท Class 3

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

0510(k)s in 12 months (0 all time)
0recalls in 12 months (269 all time)
59recalls that name a 510(k)
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Top companies in NJL

Company510(k)sRecalls
DePuy Orthopaedics, Inc.0251
Zimmer Biomet, Inc.011
Zimmer Inc.05
Exactech, Inc.01
ZIMMER ORTHOPEDIC MFG LTD01
DateFirm and productCodeLinked 510(k)
Aug 10, 2021DePuy Orthopaedics, Inc.
TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in
Terminated
NJLNone listed
Aug 10, 2021DePuy Orthopaedics, Inc.
TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in
Terminated
NJLNone listed
Aug 10, 2021DePuy Orthopaedics, Inc.
TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in
Terminated
NJLNone listed
Aug 10, 2021DePuy Orthopaedics, Inc.
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component
Terminated
NJLNone listed
Aug 10, 2021DePuy Orthopaedics, Inc.
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in
Terminated
NJLNone listed
Aug 10, 2021DePuy Orthopaedics, Inc.
TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in
Terminated
NJLNone listed
Aug 10, 2021DePuy Orthopaedics, Inc.
TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component i
Terminated
NJLNone listed
Feb 22, 2021DePuy Orthopaedics, Inc.
The ATTUNE Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
Terminated
NJLNone listed
Feb 22, 2021DePuy Orthopaedics, Inc.
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee
Terminated
NJLNone listed
Oct 10, 2019Zimmer Biomet, Inc.
LPS-MOB ART SURF IMPL D 9MM
Terminated
NJLNone listed
Nov 29, 2017Zimmer Biomet, Inc.
PRCT MIS CR MOB PLT SZ 4 L PRCT MIS CR MOB PLT SZ 5 L PRCT MIS CR MOB PLT SZ 6 L PRCT MIS CR MOB PLT SZ 7 L PRCT MIS CR MOB PLT SZ 7 R PRCT MIS CR MOB PLT SZ 8 L PRCT MIS CR MOB PLT SZ 8 R This devic
Terminated
NJLNone listed
Nov 29, 2017Zimmer Biomet, Inc.
NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability
Terminated
NJLK991581
Nov 29, 2017Zimmer Biomet, Inc.
LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FLEX PRECOAT FEMORAL E
Terminated
NJLK072619
K991581
Nov 29, 2017Zimmer Biomet, Inc.
LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-FLEX OPTION FEMORAL E-L LPS-FLEX OPTION FEMORAL E-R LPS-
Terminated
NJLK991581
Nov 29, 2017Zimmer Biomet, Inc.
LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and disability
Terminated
NJLK031061
K933785 +1
Nov 29, 2017Zimmer Biomet, Inc.
LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability
Terminated
NJLK031061
K933785
Nov 29, 2017Zimmer Biomet, Inc.
LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LPS FEM COMP SZ E-R LPS FEM COMP SZ F-L LPS FEM COMP SZ F-R
Terminated
NJLK960279
Nov 29, 2017Zimmer Biomet, Inc.
LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORAL E-R LPS OPTION FEMORAL F-L LPS OPTION FEMORAL F-R LPS OPTION FEMOR
Terminated
NJLK960279
Jul 24, 2017ZIMMER ORTHOPEDIC MFG LTD
NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
Terminated
NJLNone listed
Dec 3, 2016DePuy Orthopaedics, Inc.
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
Terminated
NJLNone listed
Feb 22, 2016Zimmer Biomet, Inc.
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is indicated for patients with severe knee pain and disability due
Terminated
NJLNone listed
Feb 22, 2016Zimmer Biomet, Inc.
NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes "" This device is indicated for pati
Terminated
NJLNone listed
May 26, 2015DePuy Orthopaedics, Inc.
LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
Terminated
NJLNone listed
May 26, 2015DePuy Orthopaedics, Inc.
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
Terminated
NJLNone listed
Oct 25, 2013Zimmer, Inc.
NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
Terminated
NJLNone listed
Jul 24, 2012Exactech, Inc.
Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***. The Exactech Optetrak RBK Total Kne
Terminated
NJLNone listed
Jun 25, 2009Zimmer Inc.
Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS Femoral Component Option Size D Left, sterile, Zimmer, Warsaw, IN; REF 00-5996-014-51.
Terminated
NJLNone listed
Jun 25, 2009Zimmer Inc.
Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size G Left , sterile, Zimmer, Warsaw, IN; REF 00-5964-017-51.
Terminated
NJLNone listed
Jun 25, 2009Zimmer Inc.
Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size D Left, sterile, Zimmer, Warsaw, IN; REF 00-5964-014-51.
Terminated
NJLNone listed
Jun 25, 2009Zimmer Inc.
Zimmer NexGen Complete Knee Solution Legacy Knee - Posterior Stabilized LPS-Flex Femoral Component Precoat, Size D left , sterile, Zimmer, Warsaw, IN; REF 00-5960-014-51.
Terminated
NJLNone listed
Sep 17, 2008Depuy Orthopaedics, Inc.
Depuy LCS Knee - Orthopedic knee implant. Meniscal bearing insert, Sz: STD, mm thick 12 5, sterile; Depuy Orthopaedics, Inc., Warsaw, IN; REF 1178-21-025). Product is a prosthesis, knee, patellofemo
Terminated
NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 5, 7.0 mm, sterile; Product code/REF 1498-12-506.
Terminated
NJLK010810
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 4, 7.0 mm, sterile; Product code/REF 1498-12-406.
Terminated
NJLK010810
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 9.5 mm, sterile; Product Code/REF 1498-12-208.
Terminated
NJLK010810
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 7.0 mm, sterile; Product Code/REF 1498-12-206.
Terminated
NJLK010810
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 4, 11.5 mm, sterile; Product Code/REF 1498-11-410.
Terminated
NJLK010810
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 3, 11.5 mm, sterile; Product Code/REF 1498-11-310.
Terminated
NJLK010810
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 25 mm, 3, UHMWPE, sterile; Product Code/REF 96-2736.
Terminated
NJLK963117
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 17.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-2733.
Terminated
NJLK963117
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 15 mm, 3, UHMWPE, sterile; Product Code/REF 96-2732.
Terminated
NJLK963117
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-2731.
Terminated
NJLK963117
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 10 mm, 3, UHMWPE, sterile; Product Code/REF 96-2730.
Terminated
NJLK963117
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 17.5 mm, 2, UHMWPE, sterile; Product Code/REF 96-2713.
Terminated
NJLK950010
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 15 mm, 2, UHMWPE, sterile; Product Code/REF 96-2712.
Terminated
NJLK950010
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, 4, UHMWPE, sterile; Product Code/REF 96-2652.
Terminated
NJLK950010
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 8.0mm, 4, UHMWPE, sterile; Product Code/REF 96-2650.
Terminated
NJLK950010
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 71mm M/L, 47mm A/P, 15.0mm, 3, UHMWPE, sterile; REF Product Code/96-2643.
Terminated
NJLK950010
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 17.5 mm, Size 6, UHMWPE, sterile; Product Code/REF 96-2164.
Terminated
NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, Size 6, UHMWPE, sterile; Product Code/REF 96-2161.
Terminated
NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2142.
Terminated
NJLNone listed

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