DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM

FDA 510(k) clearance K080991 · decided 2008-07-02

Clearance details

K-number: K080991
Device name: DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
Decision: Substantially Equivalent
Date received: 2008-04-07
Decision date: 2008-07-02
Days to decision: 86 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 300 Size 64, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cup compo recall (Z-1805-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR 300 Size 66, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cup compo recall (Z-1806-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR 300 Size 68, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cup compo recall (Z-1807-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR 300 Size 70, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cup compo recall (Z-1808-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR CUPS 64, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cu recall (Z-1809-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR CUPS 66, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cu recall (Z-1810-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR CUPS 68, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR XL Modul recall (Z-1811-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR ACETABULAR CUPS 70, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cu recall (Z-1812-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 57, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR Acetabular recall (Z-1813-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 59, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR Acetabular recall (Z-1814-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 61, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR Acetabular recall (Z-1815-2011)	Depuy Orthopaedics, Inc.	2011-03-24
ASR UNI FEMORAL IMPL SIZE 63, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR Acetabular recall (Z-1816-2011)	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, 44 mm, 999800744, sterile, DePuy International, Ltd, Lee recall (Z-2031-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 46 mm, 999800746, sterile, DePuy International, Ltd, Lee recall (Z-2032-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 100 Acetabular Implant, 48 mm, 999800748, sterile, DePuy International, Ltd, Lee recall (Z-2033-2010)	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
DePuy ASR 300 Acetabular Implant, 62 mm, 999830762, sterile, DePuy International, Ltd, Lee recall (Z-2055-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 64 mm, 999830764, sterile, DePuy International, Ltd, Lee recall (Z-2056-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 66 mm, 999830766, sterile, DePuy International, Ltd, Lee recall (Z-2057-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 68 mm, 999830768, sterile, DePuy International, Ltd, Lee recall (Z-2058-2010)	Depuy Orthopaedics, Inc.	2010-07-17
DePuy ASR 300 Acetabular Implant, 70 mm, 999830770, sterile, DePuy International, Ltd, Lee recall (Z-2059-2010)	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