510(k) K040627 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
DEPUY ASR MODULAR ACETABULAR CUP SYSTEM
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 5, 2005 |
| Received | Mar 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040627
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2011 | Depuy 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 |
KWA | None listed |
| Mar 24, 2011 | Depuy 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 |
KWA | None listed |
| Mar 24, 2011 | Depuy 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 |
KWA | None listed |
| Mar 24, 2011 | Depuy 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 |
KWA | None listed |
| Mar 24, 2011 | Depuy 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 |
KWA | None listed |
| Mar 24, 2011 | Depuy 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 |
KWA | None listed |
| Mar 24, 2011 | Depuy 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 |
KWA | None listed |
| Mar 24, 2011 | Depuy 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 |
KWA | None listed |
| Mar 24, 2011 | Depuy 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 |
KWA | None listed |
| Mar 24, 2011 | Depuy 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 |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. TOTAL ASR ACET IMP SIZE 64, 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 ace Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. TOTAL ASR ACET IMP SIZE 66, 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 ac Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. TOTAL ASR ACET IMP SIZE 70, 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 ace Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 39, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular c Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 41, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 45, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 46, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 47, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 49, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 51, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 53, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR UNI FEMORAL IMPL SIZE 55, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR TAP SLV ADAP 11/13 +0, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY or ULTIMA* UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal aceta Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR TAP SLV ADAP 11/13 +3, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acet Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR TAP SLV ADAP 11/13 +6, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acet Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR TAP SLV ADAP 11/13 +9, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY.
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal aceta Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR TAP SLV ADAP 12/14 +2, DEPUY ASR ACETABULAR CUP SYSTEM, ASR MODULAR ACETABULAR CUP SYSTEM (TRADITIONAL) (A.K.A. ASR XL).
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acet Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR TAP SLV ADAP 12/14 +5, DEPUY ASR ACETABULAR CUP SYSTEM, ASR ACETABULAR CUP SYSTEM (TRADITIONAL) (A.K.A. ASR XL).
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR TAP SLV ADAP 12/14 +8, DEPUY ASR ACETABULAR CUP SYSTEM, ASR ACETABULAR CUP SYSTEM (TRADITIONAL) (A.K.A. ASR XL).
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular 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.