KXA · Class II · 21 CFR 888.3400

FDA Product Code KXA: Prosthesis, Hip, Femoral, Resurfacing

Leading manufacturers include Corin USA, Waldemar Link GmbH & Co. KG and Orthomet, Inc..

23
Total
23
Cleared
93d
Avg days
1977
Since

FDA 510(k) Cleared Prosthesis, Hip, Femoral, Resurfacing Devices (Product Code KXA)

23 devices
1–23 of 23
Cleared Jan 19, 2021
Biocore9 Femoral Head Resurfacing Component
K201219
Biocore9, LLC
Orthopedic · 258d
Cleared Apr 15, 2010
CORMET CEMENTLESS RESURFACING FEMORAL HEAD
K092198
Corin USA
Orthopedic · 268d
Cleared Dec 12, 2008
CONSERVE PRESSFIT FEMORAL COMPONENT
K082673
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Jun 29, 2007
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
K071053
Biomet, Inc.
Orthopedic · 77d
Cleared Apr 26, 2007
DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
K070292
Zimmer GmbH
Orthopedic · 85d
Cleared Dec 01, 2006
CONSERVE FEMORAL RESURFACING COMPONENT
K062960
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared May 18, 2005
BIOPRO TARA FEMORAL RESURFACING COMPONENT
K043542
Biopro, Inc.
Orthopedic · 146d
Cleared Dec 04, 2003
DEPUY ASR RESURFACING FEMORAL HEADS
K032659
DePuy Orthopaedics, Inc.
Orthopedic · 98d
Cleared Dec 11, 2002
PRESS-FIT HEAD RESURFACING DEVICE
K023188
Biomet Orthopedics, Inc.
Orthopedic · 78d
Cleared Jun 26, 2002
CEMENTED FEMORAL HEAD RESURFING DEVICE
K021799
Biomet Orthopedics, Inc.
Orthopedic · 26d
Cleared Feb 25, 2000
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
K994153
Corin USA
Orthopedic · 79d
Cleared Dec 03, 1998
NELSON RESURFACING HEAD
K983452
Biomet, Inc.
Orthopedic · 64d
Cleared Apr 13, 1995
MODUILAR UNIPOLAR
K950998
Intermedics Orthopedics
Orthopedic · 41d
Cleared Dec 28, 1994
ORTHOMET RESURFACING FEMORAL COMPONENT
K944752
Orthomet, Inc.
Orthopedic · 93d
Cleared Nov 17, 1989
BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
K894604
Biopro, Inc.
Orthopedic · 120d
Cleared May 23, 1989
BIPOLAR HIP SYSTEM
K892398
Orthomet, Inc.
Orthopedic · 46d
Cleared Dec 05, 1979
TILLMAN HIP RESURFACING REPLACEMT PROS.
K792200
Waldemar Link GmbH & Co. KG
Orthopedic · 34d
Cleared Sep 20, 1978
TILLMAN HIPSURFACE REPLACEMENT
K781490
Waldemar Link GmbH & Co. KG
Orthopedic · 23d

About Product Code KXA - Regulatory Context