LWJ · Class II · 21 CFR 888.3360

FDA Product Code LWJ: Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

Leading manufacturers include Plus Orthopedics, Osteonics Corp. and Stelkast Company.

81
Total
81
Cleared
144d
Avg days
1984
Since

FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented Devices (Product Code LWJ)

81 devices
1–24 of 81
Cleared Oct 12, 2012
UNISYN PLUS HIP STEM
K120595
Consensus Orthopedics, Inc.
Orthopedic · 227d
Cleared Mar 09, 2011
TRINITY ACETABULAR SYSTEM
K103518
Corin USA
Orthopedic · 99d
Cleared Apr 21, 2009
NOVATION CFS PRESS-FIT AND CEMENTED STEMS
K090764
Exactech, Inc.
Orthopedic · 29d
Cleared Sep 09, 2008
METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD
K082146
Aesculap Implant Systems, Inc.
Orthopedic · 41d
Cleared Jan 31, 2007
36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
K070061
Hayes Medical, Inc.
Orthopedic · 26d
Cleared Jan 16, 2007
U2 HIP STEM, TI PLASMA SPRAY
K062978
United Orthopedic Corp.
Orthopedic · 109d
Cleared Dec 21, 2006
UNISYN HA PLASMA MODULAR HIP
K062383
Hayes Medical, Inc.
Orthopedic · 128d
Cleared Aug 18, 2006
EXCIA
K061699
Aesculap, Inc.
Orthopedic · 63d
Cleared Nov 18, 2005
BETACONE HIP PROSTHESIS SYSTEM
K051826
Waldemar Link GmbH & Co. KG
Orthopedic · 136d
Cleared Aug 15, 2005
U2 ACETABULAR COMPONENT
K050262
United Orthopedic Corp.
Orthopedic · 192d
Cleared Mar 16, 2005
EXCIA TOTAL HIP SYSTEM
K042344
Aesculap, Inc.
Orthopedic · 198d
Cleared Jan 25, 2005
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
K040685
Osteoimplant Technology, Inc.
Orthopedic · 315d
Cleared Jul 28, 2004
QUATRO M FEMORAL COMPONENT
K033313
Whiteside Biomechanics, Inc.
Orthopedic · 287d
Cleared Sep 23, 2003
MODULAR PLUS HIP STEM
K032709
Plus Orthopedics
Orthopedic · 21d
Cleared Sep 22, 2003
PROCLASS PRESS FIT HIP STEM
K032110
Stelkast Company
Orthopedic · 75d
Cleared Apr 24, 2003
MODIFICATION TO MODULAR PLUS REVISION STEM
K030971
Plus Orthopedics
Orthopedic · 27d
Cleared Mar 20, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
K023692
Howmedica Osteonics Corp.
Orthopedic · 136d
Cleared Feb 05, 2003
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
K030122
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Jan 15, 2003
UNI HIP STEM
K024134
Plus Orthopedics
Orthopedic · 30d
Cleared Oct 02, 2002
PROXILOCK HIP PROSTHESIS
K022966
Implex Corp.
Orthopedic · 26d
Cleared Feb 23, 2001
TRITON HIP SYSTEM
K003649
Hayes Medical, Inc.
Orthopedic · 88d
Cleared Feb 15, 2001
TRI-FIT FEMORAL STEM
K010243
Corin USA
Orthopedic · 21d
Cleared Dec 13, 2000
PRO-FEMUR R
K003016
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Dec 11, 2000
EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
K994146
Plus Orthopedics
Orthopedic · 369d

About Product Code LWJ - Regulatory Context