KWA · Class III · 21 CFR 888.3330

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

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

114
Total
114
Cleared
119d
Avg days
1978
Since
114 devices
49–72 of 114
Cleared Aug 28, 2006
DUPUY S-ROM STD HIP STEM PROSTHESIS
K061221
DePuy Orthopaedics, Inc.
Orthopedic · 118d
Cleared Jul 27, 2006
M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
K061423
Biomet Manufacturing Corp
Orthopedic · 65d
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 Mar 16, 2006
DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
K053536
Zimmer GmbH
Orthopedic · 87d
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 Dec 06, 2005
POROUS TITANIUM ACETABULAR AUGMENTS
K052888
Biomet Manufacturing Corp
Orthopedic · 54d
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 Nov 04, 2004
METAL/METAL HIP SYSTEM
K040354
Encore Medical, L.P.
Orthopedic · 266d
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 Dec 10, 2002
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER
K023786
DePuy Orthopaedics, Inc.
Orthopedic · 27d
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 Mar 07, 2001
ALLOFIT ACETABULAR SYSTEM
K003758
Sulzer Orthopedics, Inc.
Orthopedic · 91d
Cleared Jan 25, 2001
FMP METAL/METAL ACETABULAR INSERT
K003250
Encore Orthopedics, Inc.
Orthopedic · 100d