# K073413: Depuy Asr 300 Acetabular Cup System

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jan 30, 2008 after 57 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 36 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930712 (1993). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 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.
- K000306: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K823145: Porocoat Lunceford Acetabulum. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K080991: Depuy Asr XL Modular Acetabular Cup System (2008), 0 descendants of its own

## Recalls of this device
- Aug 23, 2010 · Not classified · Z-1803-2011: 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-1799-2011: 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-1798-2011: 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-1796-2011: 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-1802-2011: 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-1801-2011: 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-1795-2011: 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-1804-2011: 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-1800-2011: 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-1797-2011: 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-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-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-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 device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application.

Source page: https://510kreport.com/device/K073413
Methodology: https://510kreport.com/methodology