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

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 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 Dec 22, 2010
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS
K102565
Wrightmedicaltechnologyinc
Orthopedic · 106d
Cleared Sep 03, 2010
TAPERLOC COMPLETE
K101086
Biomet, Inc.
Orthopedic · 137d
Cleared Apr 30, 2010
RINGLOC + HYBRID ACETABULAR SYSTEM
K093235
Biomet, Inc.
Orthopedic · 197d
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
Cleared Mar 06, 2009
DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER
K082924
Wrightmedicaltechnologyinc
Orthopedic · 156d
Cleared Mar 06, 2009
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K083642
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Dec 04, 2008
DEPUY ASPHERE M-SPEC HEAD
K082585
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Oct 15, 2008
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
K082446
Biomet, Inc.
Orthopedic · 51d
Cleared Jul 02, 2008
DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
K080991
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared May 15, 2008
PROFEMUR LX 5/8 COATED HIP STEM
K081090
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared May 06, 2008
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM
K081007
Zimmer, Inc.
Orthopedic · 28d
Cleared Apr 08, 2008
PROFEMUR LX REVISION 5/8 COATED HIP STEM
K080663
Wrightmedicaltechnologyinc
Orthopedic · 29d

About Product Code KWA - Regulatory Context