KWA · Class III · 21 CFR 888.3330

FDA Product Code KWA: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

Leading manufacturers include Wrightmedicaltechnologyinc, Biomet, Inc. and DePuy Orthopaedics, Inc..

114
Total
114
Cleared
119d
Avg days
1978
Since
114 devices
25–48 of 114
Cleared Jan 30, 2008
DEPUY ASR 300 ACETABULAR CUP SYSTEM
K073413
DePuy Orthopaedics, Inc.
Orthopedic · 57d
Cleared Jul 30, 2007
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES
K071856
Zimmer, Inc.
Orthopedic · 25d
Cleared Mar 06, 2007
DEPUY ASR TAPER SLEEVE ADAPTER
K070359
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Jan 24, 2007
ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY
K063251
Zimmer, Inc.
Orthopedic · 89d
Cleared Dec 15, 2006
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K062426
DePuy Orthopaedics, Inc.
Orthopedic · 119d
Cleared Aug 28, 2006
DUPUY S-ROM STD HIP STEM PROSTHESIS
K061221
DePuy Orthopaedics, Inc.
Orthopedic · 118d
Cleared May 10, 2006
PROFEMUR TL HIP STEM
K060358
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Apr 18, 2006
CONSERVE PLUS QUADRAFIX ACETABULAR SHELL
K060356
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Jan 27, 2006
PROFEMUR XTR HIP STEM
K052915
Wrightmedicaltechnologyinc
Orthopedic · 102d
Cleared Jan 13, 2006
PROFEMUR LX HIP STEM
K053588
Wrightmedicaltechnologyinc
Orthopedic · 21d
Cleared Oct 04, 2005
POROUS COATED ACETABULAR COMPONENTS
K050124
Biomet, Inc.
Orthopedic · 258d
Cleared Sep 29, 2005
LINEAGE HA ACETABULAR SHELLS
K043099
Wrightmedicaltechnologyinc
Orthopedic · 324d
Cleared Aug 05, 2005
DEPUY ASR MODULAR ACETABULAR CUP SYSTEM
K040627
DePuy Orthopaedics, Inc.
Orthopedic · 514d
Cleared Aug 05, 2005
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM
K043547
Biomet, Inc.
Orthopedic · 225d
Cleared May 27, 2005
BALANCE HIP SYSTEM
K050251
Biomet, Inc.
Orthopedic · 113d
Cleared May 04, 2005
PROCOTYL-E ACETABULAR SYSTEM
K043073
Wrightmedicaltechnologyinc
Orthopedic · 177d
Cleared Dec 17, 2004
CONSERVE PLUS HA ACETABULAR SHELLS
K042530
Wrightmedicaltechnologyinc
Orthopedic · 91d
Cleared Oct 01, 2004
M2A MAGNUM SYSTEM
K042037
Biomet, Inc.
Orthopedic · 64d
Cleared Jun 25, 2004
CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL
K041425
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Oct 31, 2003
CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD
K031963
Wrightmedicaltechnologyinc
Orthopedic · 128d
Cleared Jul 01, 2002
METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
K021349
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Jul 02, 2001
M2A ACETABULAR SYSTEM
K011110
Biomet, Inc.
Orthopedic · 82d
Cleared Aug 31, 2000
M2A 28MM RINGLOC LINER
K002379
Biomet, Inc.
Orthopedic · 27d
Cleared May 18, 2000
METAL ON METAL ACETABULAR SYSTEM
K993438
Biomet, Inc.
Orthopedic · 219d