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)
Top companies in NJL
| Company | 510(k)s | Recalls |
|---|---|---|
| DePuy Orthopaedics, Inc. | 0 | 251 |
| Zimmer Biomet, Inc. | 0 | 11 |
| Zimmer Inc. | 0 | 5 |
| Exactech, Inc. | 0 | 1 |
| ZIMMER ORTHOPEDIC MFG LTD | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2021 | DePuy 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 |
NJL | None listed |
| Aug 10, 2021 | DePuy 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 |
NJL | None listed |
| Aug 10, 2021 | DePuy 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 |
NJL | None listed |
| Aug 10, 2021 | DePuy 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 |
NJL | None listed |
| Aug 10, 2021 | DePuy 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 |
NJL | None listed |
| Aug 10, 2021 | DePuy 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 |
NJL | None listed |
| Aug 10, 2021 | DePuy 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 |
NJL | None listed |
| Feb 22, 2021 | DePuy 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 |
NJL | None listed |
| Feb 22, 2021 | DePuy 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 |
NJL | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. LPS-MOB ART SURF IMPL D 9MM Terminated |
NJL | None listed |
| Nov 29, 2017 | Zimmer 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 |
NJL | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT
This device is indicated for patients with severe knee pain and disability Terminated |
NJL | K991581 |
| Nov 29, 2017 | Zimmer 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 |
NJL | K072619 K991581 |
| Nov 29, 2017 | Zimmer 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 |
NJL | K991581 |
| Nov 29, 2017 | Zimmer 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 |
NJL | K031061 K933785 +1 |
| Nov 29, 2017 | Zimmer 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 |
NJL | K031061 K933785 |
| Nov 29, 2017 | Zimmer 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 |
NJL | K960279 |
| Nov 29, 2017 | Zimmer 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 |
NJL | K960279 |
| Jul 24, 2017 | ZIMMER 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 |
NJL | None listed |
| Dec 3, 2016 | DePuy Orthopaedics, Inc. LCS Complete Knee Revision System VVC Insert
Product Usage:
LCS VVC Insert is used in Knee Revision Surgery Terminated |
NJL | None listed |
| Feb 22, 2016 | Zimmer 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 |
NJL | None listed |
| Feb 22, 2016 | Zimmer 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 |
NJL | None listed |
| May 26, 2015 | DePuy Orthopaedics, Inc. LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery. Terminated |
NJL | None listed |
| May 26, 2015 | DePuy Orthopaedics, Inc. LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery. Terminated |
NJL | None listed |
| Oct 25, 2013 | Zimmer, Inc. NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States) Terminated |
NJL | None listed |
| Jul 24, 2012 | Exactech, 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 |
NJL | None listed |
| Jun 25, 2009 | Zimmer 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 |
NJL | None listed |
| Jun 25, 2009 | Zimmer 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 |
NJL | None listed |
| Jun 25, 2009 | Zimmer 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 |
NJL | None listed |
| Jun 25, 2009 | Zimmer 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 |
NJL | None listed |
| Sep 17, 2008 | Depuy 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 |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 5, 7.0 mm, sterile; Product code/REF 1498-12-506. Terminated |
NJL | K010810 |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 4, 7.0 mm, sterile; Product code/REF 1498-12-406. Terminated |
NJL | K010810 |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 9.5 mm, sterile; Product Code/REF 1498-12-208. Terminated |
NJL | K010810 |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 7.0 mm, sterile; Product Code/REF 1498-12-206. Terminated |
NJL | K010810 |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 4, 11.5 mm, sterile; Product Code/REF 1498-11-410. Terminated |
NJL | K010810 |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 3, 11.5 mm, sterile; Product Code/REF 1498-11-310. Terminated |
NJL | K010810 |
| Dec 6, 2007 | Depuy 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 |
NJL | K963117 |
| Dec 6, 2007 | Depuy 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 |
NJL | K963117 |
| Dec 6, 2007 | Depuy 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 |
NJL | K963117 |
| Dec 6, 2007 | Depuy 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 |
NJL | K963117 |
| Dec 6, 2007 | Depuy 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 |
NJL | K963117 |
| Dec 6, 2007 | Depuy 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 |
NJL | K950010 |
| Dec 6, 2007 | Depuy 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 |
NJL | K950010 |
| Dec 6, 2007 | Depuy 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 |
NJL | K950010 |
| Dec 6, 2007 | Depuy 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 |
NJL | K950010 |
| Dec 6, 2007 | Depuy 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 |
NJL | K950010 |
| Dec 6, 2007 | Depuy 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 |
NJL | None listed |
| Dec 6, 2007 | Depuy 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 |
NJL | None listed |
| Dec 6, 2007 | Depuy 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 |
NJL | None listed |
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