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

FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) Devices (Product Code KWA)

114 devices
1–24 of 114
Cleared Oct 11, 2012
PROFEMUR Z REVISION HIP STEM
K122778
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Jul 30, 2012
DYNASTY BIOFOAM SHELL
K121544
Wrightmedicaltechnologyinc
Orthopedic · 66d
Cleared Feb 03, 2012
CONSERVE THIN SHELL
K113322
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Dec 28, 2011
PRESERVE HIP STEM
K112080
Wrightmedicaltechnologyinc
Orthopedic · 160d
Cleared Nov 23, 2011
PROFEMUR GLADIATOR HA HIP STEM
K112150
Wrightmedicaltechnologyinc
Orthopedic · 119d
Cleared Nov 10, 2011
PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER
K113019
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Oct 14, 2011
GLADIATOR HIP STEM
K111910
Wrightmedicaltechnologyinc
Orthopedic · 101d
Cleared Oct 07, 2011
CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
K110836
Zimmer GmbH
Orthopedic · 196d
Cleared Sep 30, 2011
TAPERLOC COMPLETE MICROPLASTY STEM
K110400
Biomet Manufacturing Corp
Orthopedic · 231d
Cleared Aug 19, 2011
PROFEMUR(R) E CEMENTLESS HIP STEM
K111698
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Aug 19, 2011
PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM
K111699
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared May 10, 2011
GLADIATOR PLASMA CLASSIC HIP STEM
K110399
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Apr 19, 2011
CONSERVE BIO FOAM SHELL
K110029
Wrightmedicaltechnologyinc
Orthopedic · 104d
Cleared Jan 21, 2011
TAPERLOC COMPLETE, SIZE 5 AND 6
K103755
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Dec 22, 2010
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS
K102565
Wrightmedicaltechnologyinc
Orthopedic · 106d
Cleared Dec 07, 2010
ARCOS INTERLOCKING DISTAL STEMS
K100469
Biomet Manufacturing Corp
Orthopedic · 292d
Cleared Sep 03, 2010
TAPERLOC COMPLETE
K101086
Biomet, Inc.
Orthopedic · 137d
Cleared Jun 18, 2010
COMPRESS ANTI-ROTATION SPINDLES
K101475
Biomet Manufacturing Corp
Orthopedic · 21d
Cleared Apr 30, 2010
RINGLOC + HYBRID ACETABULAR SYSTEM
K093235
Biomet, Inc.
Orthopedic · 197d
Cleared Mar 03, 2010
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200
K092331
Encore Medical, L.P.
Orthopedic · 211d
Cleared Nov 24, 2009
ZIMMER MMC CUP
K091003
Zimmer GmbH
Orthopedic · 230d
Cleared Nov 17, 2009
METASUL TAPER LINERS, METASUL FEMORAL HEADS
K091973
Zimmer GmbH
Orthopedic · 139d
Cleared Sep 25, 2009
BIOMET MODULAR FEMORAL REVISION SYSTEM
K090757
Biomet, Inc.
Orthopedic · 186d
Cleared Aug 25, 2009
PROFEMUR HIP SYSTEM MODULAR NECKS
K091423
Wrightmedicaltechnologyinc
Orthopedic · 104d

About Product Code KWA - Regulatory Context