# K080991: Depuy Asr XL Modular Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jul 2, 2008 after 86 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 41 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K935452 (1994). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040627: Depuy Asr Modular Acetabular Cup System, DePuy Orthopaedics, Inc. (2005) Summary page 1.
- K073413: Depuy Asr 300 Acetabular Cup System, DePuy Orthopaedics, Inc. (2008) Summary page 1.
- K021349: Metal Transcend Articulation System (Larger Sizes), Wrightmedicaltechnologyinc (2002) Summary page 1.
- K965156: Ultima*Unipolar Head and Adapter Sleeves, Johnson & Johnson Professionals, Inc. (1997) Summary page 1.
- K070359: Depuy Asr Taper Sleeve Adapter, DePuy Orthopaedics, Inc. (2007) Summary page 1.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 1.
- K073570: Depuy Tri-Lock Bone Preservation Stem, DePuy Orthopaedics, Inc. (2008) Summary page 1.

## Recalls of this device
- Aug 23, 2010 · Not classified · Z-1811-2011: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, c
- Aug 23, 2010 · Not classified · Z-1814-2011: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, c
- Aug 23, 2010 · Not classified · Z-1815-2011: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, c
- Aug 23, 2010 · Not classified · Z-1807-2011: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, c
- Aug 23, 2010 · Not classified · Z-1812-2011: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, c
- Aug 23, 2010 · Not classified · Z-1808-2011: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, c
- Aug 23, 2010 · Not classified · Z-1810-2011: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, c
- Aug 23, 2010 · Not classified · Z-1816-2011: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, c
- Aug 23, 2010 · Not classified · Z-1806-2011: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, c
- Aug 23, 2010 · Not classified · Z-1809-2011: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, c
- Aug 23, 2010 · Not classified · Z-1805-2011: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, c
- Aug 23, 2010 · Not classified · Z-1813-2011: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, c
- Mar 5, 2010 · Not classified · Z-2048-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2033-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2055-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2038-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2049-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2056-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2053-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2057-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2058-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2050-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2037-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2044-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2031-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2042-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2054-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-203-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2046-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2059-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2051-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2035-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2047-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2032-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2043-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2040-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2039-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2045-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2041-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2052-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source
- Mar 5, 2010 · Not classified · Z-2036-2010: Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of source

## Indications for use
The DePuy ASR XL Modular Acetabular Cup System is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemi-arthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR XL Modular Acetabular Cups are indicated for cementless application.

Source page: https://510kreport.com/device/K080991
Methodology: https://510kreport.com/methodology