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
25–48 of 114
Cleared Mar 13, 2009
REVELATION STEM, MODEL 427-21/42-080/180
K083651
Encore Medical, L.P.
Orthopedic · 94d
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
Cleared Mar 20, 2008
PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS
K073637
Biomet Manufacturing Corp
Orthopedic · 85d
Cleared Mar 07, 2008
ZIMMER POROLOCK MIS STEM
K071723
Zimmer GmbH
Orthopedic · 256d
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 Apr 04, 2007
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
K070221
Encore Medical, L.P.
Orthopedic · 70d
Cleared Apr 03, 2007
ECHO BI-METRIC PRESS-FIT STEMS
K070274
Biomet Manufacturing Corp
Orthopedic · 64d
Cleared Mar 09, 2007
LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS
K062994
Biomet Manufacturing Corp
Orthopedic · 158d
Cleared Mar 06, 2007
DEPUY ASR TAPER SLEEVE ADAPTER
K070359
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Feb 20, 2007
ALTRA FX HIP SYSTEM
K063614
Biomet Manufacturing Corp
Orthopedic · 77d
Cleared Jan 24, 2007
ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY
K063251
Zimmer, Inc.
Orthopedic · 89d
Cleared Jan 19, 2007
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)
K062998
Biomet Manufacturing Corp
Orthopedic · 109d
Cleared Dec 15, 2006
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K062426
DePuy Orthopaedics, Inc.
Orthopedic · 119d
Cleared Dec 12, 2006
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38
K063414
Encore Medical, L.P.
Orthopedic · 29d
Cleared Oct 31, 2006
M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
K062995
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Oct 31, 2006
ALTRA PRESS-FIT HIP SYSTEM
K063002
Biomet Manufacturing Corp
Orthopedic · 29d