DEPUY ASR MODULAR ACETABULAR CUP SYSTEM

FDA 510(k) clearance K040627 · decided 2005-08-05

Clearance details

K-number: K040627
Device name: DEPUY ASR MODULAR ACETABULAR CUP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
Decision: Substantially Equivalent
Date received: 2004-03-09
Decision date: 2005-08-05
Days to decision: 514 days
Clearance type: Traditional
Product code: KWA
Device class: 3
Regulation number: 888.3330
Medical specialty: Orthopedic
Advisory committee: Orthopedic
Location: Warsaw, IN, US
Third-party review: No
Expedited review: No

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Recalls involving this device

Record	Firm	Date
ASR ACETABULAR IMPLANT 44, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replac recall (Z-1749-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR IMPLANT 46, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replac recall (Z-1750-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR IMPLANT 48, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replac recall (Z-1751-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR IMPLANT 50, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replac recall (Z-1752-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR IMPLANT 52, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replac recall (Z-1753-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR IMPLANT 54, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replac recall (Z-1754-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR IMPLANT 56, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replac recall (Z-1755-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR IMPLANT 58, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replac recall (Z-1756-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR IMPLANT 60, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replac recall (Z-1757-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR IMPLANT 62, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replac recall (Z-1758-2011)	Depuy Orthopaedics, Inc.	2011-03-24
TOTAL ASR ACET IMP SIZE 64, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Repla recall (Z-1759-2011)	Depuy Orthopaedics, Inc.	2011-03-24
TOTAL ASR ACET IMP SIZE 66, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Repla recall (Z-1760-2011)	Depuy Orthopaedics, Inc.	2011-03-24
TOTAL ASR ACET IMP SIZE 70, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Repla recall (Z-1762-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 39, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surfac recall (Z-1776-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 41, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surfac recall (Z-1777-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 45, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surfac recall (Z-1779-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 46, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surfac recall (Z-1780-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 47, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surfac recall (Z-1781-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 49, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surfac recall (Z-1782-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 51, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surfac recall (Z-1783-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 53, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surfac recall (Z-1784-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 55, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surfac recall (Z-1785-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR TAP SLV ADAP 11/13 +0, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY or ULTIMA* UNIPOLAR HEA recall (Z-1786-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR TAP SLV ADAP 11/13 +3, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA*UNIPOLAR HEA recall (Z-1787-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR TAP SLV ADAP 11/13 +6, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA*UNIPOLAR HEA recall (Z-1788-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR TAP SLV ADAP 11/13 +9, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA UNIPOLAR HEA recall (Z-1789-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR TAP SLV ADAP 12/14 +2, DEPUY ASR ACETABULAR CUP SYSTEM, ASR MODULAR ACETABULAR CUP SYS recall (Z-1790-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR TAP SLV ADAP 12/14 +5, DEPUY ASR ACETABULAR CUP SYSTEM, ASR ACETABULAR CUP SYSTEM (TRA recall (Z-1791-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR TAP SLV ADAP 12/14 +8, DEPUY ASR ACETABULAR CUP SYSTEM, ASR ACETABULAR CUP SYSTEM (TRA recall (Z-1794-2011)	Depuy Orthopaedics, Inc.	2011-03-24
DePuy ASR 100 Acetabular Implant, 50 mm, 999800750, sterile, DePuy International, Ltd, Lee recall (Z-203-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 52 mm, 999800752, sterile, DePuy International, Ltd, Lee recall (Z-2035-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 54 mm, 999800754, sterile, DePuy International, Ltd, Lee recall (Z-2036-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 56 mm, 999800756, sterile, DePuy International, Ltd, Lee recall (Z-2037-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 57 mm, 999890157, sterile, DePuy International, Ltd, Lee recall (Z-2038-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 58 mm, 999800758, sterile, DePuy International, Ltd, Lee recall (Z-2039-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 66 mm, 999805966, sterile, DePuy International, Ltd, Lee recall (Z-2040-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 60 mm, 999800760, sterile, DePuy International, Ltd, Lee recall (Z-2041-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 62 mm, 999800762, sterile, DePuy International, Ltd, Lee recall (Z-2042-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 64 mm, 999805764, sterile, DePuy International, Ltd, Lee recall (Z-2043-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 68 mm, 999806168, sterile, DePuy International, Ltd, Lee recall (Z-2044-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 70 mm, 999806370, sterile, DePuy International, Ltd, Lee recall (Z-2045-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 44 mm, 999830744, sterile, DePuy International, Ltd, Lee recall (Z-2046-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 46 mm, 999830746, sterile, DePuy International, Ltd, Lee recall (Z-2047-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 48 mm, 999830748, sterile, DePuy International, Ltd, Lee recall (Z-2048-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 50 mm, 999830750, sterile, DePuy International, Ltd, Lee recall (Z-2049-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 52 mm, 999830752, sterile, DePuy International, Ltd, Lee recall (Z-2050-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 54 mm, 999830754, sterile, DePuy International, Ltd, Lee recall (Z-2051-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 56 mm, 999830756, sterile, DePuy International, Ltd, Lee recall (Z-2052-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 58 mm, 999830758, sterile, DePuy International, Ltd, Lee recall (Z-2053-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 60 mm, 999830760, sterile, DePuy International, Ltd, Lee recall (Z-2054-2010)	Depuy Orthopaedics, Inc.	2010-07-17

PMA approvals by this applicant

Record	Firm	Date
Ceramax Ceramic Hip System (P070026/S123)	DePuy Orthopaedics, Inc.	2025-12-09
CERAMAX CERAMIC HIP SYSTEM (P070026/S121)	DePuy Orthopaedics, Inc.	2025-08-05
CERAMAX CERAMIC HIP SYSTEM (P070026/S122)	DePuy Orthopaedics, Inc.	2025-08-01
CERAMAX® ceramic total hip system (P070026/S120)	DePuy Orthopaedics, Inc.	2025-06-24
CERAMAX CERAMIC HIP SYSTEM (P070026/S119)	DePuy Orthopaedics, Inc.	2025-04-04
DePuy Ceramax Ceramic Total Hip System (P070026/S114)	DePuy Orthopaedics, Inc.	2025-03-19
Ceramax Ceramic Hip System (P070026/S117)	DePuy Orthopaedics, Inc.	2025-02-21
Ceramax® Ceramic Total Hip System (P070026/S116)	DePuy Orthopaedics, Inc.	2025-02-11