ClearanceBrief
Panels › Orthopedic › Product code KXA · Class 2

Prosthesis, Hip, Femoral, Resurfacing

Regulation 888.3400

0510(k)s in 12 months (23 all time)
0recalls in 12 months (16 all time)
16recalls that name a 510(k)
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Top companies in KXA

Company510(k)sRecalls
DePuy Orthopaedics, Inc.113
Zimmer GmbH13
Biomet, Inc.20
Biomet Orthopedics, Inc.20
Biopro, Inc.20
Corin USA20
Orthomet, Inc.20
Waldemar Link GmbH & Co. KG20
Wrightmedicaltechnologyinc20
Biocore9, LLC10
DateFirm and productCodeLinked 510(k)
Nov 6, 2012Zimmer, Inc.
Metasul Durom Femoral component Sterile, Rx
Terminated		 KXAK070292
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR FEMORAL IMPLANT SIZE 63, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hem
Terminated		 KXAK032659
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR FEMORAL IMPLANT SIZE 61, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hem
Terminated		 KXAK032659
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR FEMORAL IMPLANT SIZE 59, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hem
Terminated		 KXAK032659
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR FEMORAL IMPLANT SIZE 57, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hem
Terminated		 KXAK032659
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR FEMORAL IMPLANT SIZE 55, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hem
Terminated		 KXAK032659
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR FEMORAL IMPLANT SIZE 53, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hem
Terminated		 KXAK032659
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR FEMORAL IMPLANT SIZE 51, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hem
Terminated		 KXAK032659
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR FEMORAL IMPLANT SIZE 49, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hem
Terminated		 KXAK032659
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR FEMORAL IMPLANT SIZE 47, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hem
Terminated		 KXAK032659
Mar 24, 2011Depuy Orthopaedics, Inc.
TOTAL ASR FEM IMP SIZE 45, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-
Terminated		 KXAK032659
Mar 24, 2011Depuy Orthopaedics, Inc.
TOTAL ASR FEM IMP SIZE 43, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-
Terminated		 KXAK032659
Mar 24, 2011Depuy Orthopaedics, Inc.
TOTAL ASR FEM IMP SIZE 41, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-
Terminated		 KXAK032659
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR FEMORAL IMPLANT SIZE 39, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hem
Terminated		 KXAK032659
Nov 29, 2007Zimmer Inc.
Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L; Catalog No.: 01.00211.146, Lot 2376766. Zimmer, Warsaw, IN, 46581-0708.
Terminated		 KXAK070292
Nov 29, 2007Zimmer Inc.
Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw, IN, 46581-0708.
Terminated		 KXAK070292

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