510(k) K080991 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 2, 2008 |
| Received | Apr 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080991
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR 300 Size 64, DEPUY ASR XL ACETABULAR CUP SYSTEM.
The DePuy ASR XL Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in tota Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR 300 Size 66, DEPUY ASR XL ACETABULAR CUP SYSTEM.
The DePuy ASR XL Acetabular Cup components are part of a system designed to replace the natural articular surface of the hip joint in total hip r Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR 300 Size 68, DEPUY ASR XL ACETABULAR CUP SYSTEM.
The DePuy ASR XL Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in tota Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR 300 Size 70, DEPUY ASR XL ACETABULAR CUP SYSTEM.
The DePuy ASR XL Acetabular Cup components are part of a system designed to replace the natural articular surface of the hip joint in total hip r Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR ACETABULAR CUPS 64, DEPUY ASR XL ACETABULAR CUP SYSTEM.
The DePuy ASR XL Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR ACETABULAR CUPS 66, DEPUY ASR XL ACETABULAR CUP SYSTEM.
The DePuy ASR XL Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR ACETABULAR CUPS 68, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM.
The DePuy ASR XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR ACETABULAR CUPS 70, DEPUY ASR XL ACETABULAR CUP SYSTEM.
The DePuy ASR XL Acetabular Cup components are part of a system designed to replace the natural articular surface of the hip joint in tota Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 57, DEPUY ASR XL ACETABULAR CUP SYSTEM.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve ad Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 59, DEPUY ASR XL ACETABULAR CUP SYSTEM.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve ad Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 61, DEPUY ASR XL ACETABULAR CUP SYSTEM.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve ad Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 63, DEPUY ASR XL ACETABULAR CUP SYSTEM.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve ad Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 44 mm, 999800744, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 46 mm, 999800746, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 48 mm, 999800748, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 50 mm, 999800750, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 52 mm, 999800752, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 54 mm, 999800754, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 56 mm, 999800756, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 57 mm, 999890157, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 58 mm, 999800758, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 66 mm, 999805966, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 60 mm, 999800760, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 62 mm, 999800762, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 64 mm, 999805764, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 68 mm, 999806168, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 100 Acetabular Implant, 70 mm, 999806370, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 44 mm, 999830744, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 46 mm, 999830746, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 48 mm, 999830748, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 50 mm, 999830750, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 52 mm, 999830752, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 54 mm, 999830754, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 56 mm, 999830756, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 58 mm, 999830758, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 60 mm, 999830760, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 62 mm, 999830762, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 64 mm, 999830764, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 66 mm, 999830766, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 68 mm, 999830768, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
| Jul 17, 2010 | Depuy Orthopaedics, Inc. DePuy ASR 300 Acetabular Implant, 70 mm, 999830770, sterile, DePuy International, Ltd, Leeds, United Kingdom. Terminated |
KWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.