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Panels › Orthopedic › Product code KWA · Class 3

Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Regulation 888.3330

0510(k)s in 12 months (114 all time)
0recalls in 12 months (203 all time)
198recalls that name a 510(k)
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Top companies in KWA

Company510(k)sRecalls
DePuy Orthopaedics, Inc.1288
Biomet, Inc.1167
Zimmer GmbH924
Wrightmedicaltechnologyinc260
Wright Medical Technology Inc016
Biomet Manufacturing Corp140
Encore Medical Corporation62
Zimmer Biomet, Inc.06
Protek, Inc.40
Advanced Biosearch Assn.30
DateFirm and productCodeLinked 510(k)
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR ACETABULAR IMPLANT 62, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acet
Terminated		 KWAK040627
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR ACETABULAR IMPLANT 60, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acet
Terminated		 KWAK040627
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR ACETABULAR IMPLANT 58, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acet
Terminated		 KWAK040627
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR ACETABULAR IMPLANT 56, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acet
Terminated		 KWAK040627
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR ACETABULAR IMPLANT 54, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acet
Terminated		 KWAK040627
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR ACETABULAR IMPLANT 52, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acet
Terminated		 KWAK040627
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR ACETABULAR IMPLANT 50, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System The DePuy ASR Acetabular Cup System is comprised of a one-piece metal aceta
Terminated		 KWAK040627
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR ACETABULAR IMPLANT 48, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acet
Terminated		 KWAK040627
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR ACETABULAR IMPLANT 46, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System The DePuy ASR Acetabular Cup System is comprised of a one-piece metal aceta
Terminated		 KWAK040627
Mar 24, 2011Depuy Orthopaedics, Inc.
ASR ACETABULAR IMPLANT 44, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acet
Terminated		 KWAK040627
Mar 7, 2011Biomet, Inc.
ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850, Biomet Orthopedics Warsaw, IN. The torque limiting T-handle is used with attachments and hex drivers for prepar
Terminated		 KWANone listed
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 70 mm, 999830770, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 68 mm, 999830768, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 66 mm, 999830766, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 64 mm, 999830764, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 62 mm, 999830762, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 60 mm, 999830760, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 58 mm, 999830758, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 56 mm, 999830756, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 54 mm, 999830754, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 52 mm, 999830752, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 50 mm, 999830750, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 48 mm, 999830748, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 46 mm, 999830746, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 44 mm, 999830744, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 70 mm, 999806370, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 68 mm, 999806168, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 64 mm, 999805764, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 62 mm, 999800762, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 60 mm, 999800760, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 66 mm, 999805966, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 58 mm, 999800758, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 57 mm, 999890157, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 56 mm, 999800756, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 54 mm, 999800754, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 52 mm, 999800752, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 50 mm, 999800750, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK040627
K073413 +1
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 48 mm, 999800748, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK080991
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 46 mm, 999800746, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK080991
Jul 17, 2010Depuy Orthopaedics, Inc.
DePuy ASR 100 Acetabular Implant, 44 mm, 999800744, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Terminated		 KWAK080991
Sep 26, 2008Zimmer Inc.
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 66/60, code Z, Zimmer, Winterthur, Switzerland; REF 01.00214.166. The product is component of the Metasul LDH Head System intended f
Terminated		 KWAK053536
Sep 26, 2008Zimmer Inc.
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 64/58, code X, Zimmer, Winterthur, Switzerland; REF 01.00214.164. The product is component of the Metasul LDH Head System intended f
Terminated		 KWAK053536
Sep 26, 2008Zimmer Inc.
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 62/56, code V, Zimmer, Winterthur, Switzerland; REF 01.00214.162. The product is component of the Metasul LDH Head System intended f
Terminated		 KWAK053536
Sep 26, 2008Zimmer Inc.
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 60/54, code T, Zimmer, Winterthur, Switzerland; REF 01.00214.160. The product is component of the Metasul LDH Head System intended
Terminated		 KWAK053536
Sep 26, 2008Zimmer Inc.
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 58/52, code R, Zimmer, Winterthur, Switzerland; REF 01.00214.158. The product is component of the Metasul LDH Head System intended fo
Terminated		 KWAK053536
Sep 26, 2008Zimmer Inc.
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 56/50, code P, Zimmer, Winterthur, Switzerland; REF 01.00214.156. The product is component of the Metasul LDH Head System intended f
Terminated		 KWAK053536
Sep 26, 2008Zimmer Inc.
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 54/48, code N, Zimmer, Winterthur, Switzerland; REF 01.00214.154. The product is component of the Metasul LDH Head System intended f
Terminated		 KWAK053536
Sep 26, 2008Zimmer Inc.
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 52/46, code L, Zimmer, Winterthur, Switzerland; REF 01.00214.152. The product is component of the Metasul LDH Head System intended fo
Terminated		 KWAK053536
Sep 26, 2008Zimmer Inc.
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 50/44, code J, Zimmer, Winterthur, Switzerland; REF 01.00214.150. The product is component of the Metasul LDH Head System intended f
Terminated		 KWAK053536
Sep 26, 2008Zimmer Inc.
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 48/42, code H, Zimmer, Winterthur, Switzerland; REF 01.00214.148. The product is component of the Metasul LDH Head System intended f
Terminated		 KWAK053536

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