# K070359: Depuy Asr Taper Sleeve Adapter

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Mar 6, 2007 after 27 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K004043 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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.
- K965156: Ultima*Unipolar Head and Adapter Sleeves, Johnson & Johnson Professionals, Inc. (1997) 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-1793-2011: 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-1792-2011: 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

## Indications for use
The DePuy ASR 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/K070359
Methodology: https://510kreport.com/methodology