ClearanceBrief
Panels › Orthopedic › Product code LWJ · Class 2

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Regulation 888.3360

0510(k)s in 12 months (81 all time)
0recalls in 12 months (26 all time)
22recalls that name a 510(k)
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Top companies in LWJ

Company510(k)sRecalls
Aesculap Implant Systems, Inc.110
Plus Orthopedics71
Zimmer, Inc.26
Stelkast Company52
Osteonics Corp.60
Encore Orthopedics, Inc.40
Howmedica Osteonics Corp.22
MicroPort Orthopedics Inc.04
Depuy, Inc.30
Hayes Medical, Inc.30
DateFirm and productCodeLinked 510(k)
Jan 31, 2024Howmedica Osteonics Corp.
P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
Open, Classified		 LWJNone listed
Jan 31, 2024Howmedica Osteonics Corp.
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
Open, Classified		 LWJNone listed
Sep 18, 2020MicroPort Orthopedics Inc.
PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component
Terminated		 LWJK003016
Sep 18, 2020MicroPort Orthopedics Inc.
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
Terminated		 LWJK003016
Sep 9, 2020MicroPort Orthopedics Inc.
PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRA
Open, Classified		 LWJK003016
K091423 +1
Aug 18, 2016MicroPort Orthopedics Inc.
PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature pati
Terminated		 LWJK003016
Feb 20, 2014Zimmer, Inc.
PRESSFIT FEM ST FX 16 X 1
Terminated		 LWJNone listed
Aug 18, 2009Stryker Howmedica Osteonics Corp.
V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., Stryker Ireland, Carrigtwohill County Cork, Ireland; Intended for use with femoral
Terminated		 LWJK022077
K993601
Jul 6, 2009Zimmer Inc.
Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile, Zimmer, Warsaw, IN; Model Number: 9982-15-18. Cement-less total hip arthroplasty in patients whose
Terminated		 LWJK992667
Mar 31, 2009Stelkast Co
Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip
Terminated		 LWJK953268
Jan 28, 2009Stelkast Co
Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439
Terminated		 LWJK953268
Dec 11, 2007Aesculap Implant Systems
Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Terminated		 LWJK042344
Dec 11, 2007Aesculap Implant Systems
Excia Cemented Hip Stems, Size 17mm, Part Number : NJ317K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Terminated		 LWJK042344
Dec 11, 2007Aesculap Implant Systems
Excia Cemented Hip Stems, Size 16mm, Part Number NJ316K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Terminated		 LWJK042344
Dec 11, 2007Aesculap Implant Systems
Excia Cemented Hip Stems, Size 15mm, Part Number: NJ315K Aesculap Implant Systems, Inc., Center Valley, PA 18034
Terminated		 LWJK042344
Dec 11, 2007Aesculap Implant Systems
Excia Cemented Hip Stems, Size 14mm, Part Number : NJ314K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Terminated		 LWJK042344
Dec 11, 2007Aesculap Implant Systems
Excia Cemented Hip Stems, Size 13mm, Part Number : NJ313K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Terminated		 LWJK042344
Dec 11, 2007Aesculap Implant Systems
Excia Cemented Hip Stems, Size 12mm, Part Number: NJ312K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Terminated		 LWJK042344
Dec 11, 2007Aesculap Implant Systems
Excia Cemented Hip Stems, Size 11mm, Part Number : NJ311K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Terminated		 LWJK042344
Dec 11, 2007Aesculap Implant Systems
Excia Cemented Hip Stems, Size 10mm, Part Number: NJ310K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Terminated		 LWJK042344
Dec 11, 2007Aesculap Implant Systems
Excia Cemented Hip Stems, Size 9mm, Part Number: NJ309K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Terminated		 LWJK042344
Aug 31, 2006Zimmer Inc.
Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 17, 150 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-17-04 (00786101704).
Terminated		 LWJK961378
Aug 31, 2006Zimmer Inc.
Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 15, 140 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-15-04 (00786101504).
Terminated		 LWJK961378
Aug 31, 2006Zimmer Inc.
Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-14-04 (00786101404).
Terminated		 LWJK961378
Aug 31, 2006Zimmer Inc.
Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium TI-6AL-4V alloy, sterile, w/calcicoat ceramic coating; Cat. no. 65
Terminated		 LWJK961378
Jan 14, 2004Plus Orthopedics
Hip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to for a femoral stem.
Terminated		 LWJNone listed

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