# K040627: Depuy Asr Modular Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Aug 5, 2005 after 514 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 55 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K004043 (2001). 5 ancestors in all.
9 later devices descend from it; 5 cite 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)
- K002883: Pinnacle Metal-on-Metal Acetabular Cup Liners, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K003523: Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners, DePuy Orthopaedics, Inc. (2000) 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.

## Most influential descendants
- K061423: M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads (2006), 3 descendants of its own
- K082446: Biomet Metal-on-Metal Hip Systems- Expanded Contraindications (2008), 2 descendants of its own
- K062426: Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners (2006), 2 descendants of its own
- K073413: Depuy Asr 300 Acetabular Cup System (2008), 1 descendant of its own
- K070359: Depuy Asr Taper Sleeve Adapter (2007), 1 descendant of its own

## Recalls of this device
- Aug 23, 2010 · Not classified · Z-1776-2011: 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-1791-2011: 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-1777-2011: 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-1782-2011: 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-1759-2011: 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-1760-2011: 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-1755-2011: 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-1750-2011: 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-1783-2011: 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-1751-2011: 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-1784-2011: 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-1756-2011: 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-1788-2011: 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-1779-2011: 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-1757-2011: 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-1794-2011: 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-1787-2011: 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-1789-2011: 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-1753-2011: 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-1780-2011: 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-1754-2011: 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-1790-2011: 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-1749-2011: 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-1786-2011: 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-1752-2011: 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-1762-2011: 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-1781-2011: 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-1785-2011: 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-1758-2011: 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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

## Indications for use
The DePuy ASR Tm Modular Acetabular Cup System 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.

Source page: https://510kreport.com/device/K040627
Methodology: https://510kreport.com/methodology