# K032659: Depuy Asr Resurfacing Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Dec 4, 2003 after 98 days
- Product code: KXA (Prosthesis, Hip, Femoral, Resurfacing)
- Device class: 2
- Regulation: 21 CFR 888.3400
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983452 (1998). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021799: Cemented Femoral Head Resurfing Device, Biomet Orthopedics, Inc. (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K810325: DePuy T.A.R.A. Total Hip Prosthesis. 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
- K043542: Biopro Tara Femoral Resurfacing Component (2005), 1 descendant of its own
- K070292: Durom Hip Resurfacing System, Femoral Components (2007), 0 descendants of its own

## Recalls of this device
- Aug 23, 2010 · Not classified · Z-1772-2011: 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-1764-2011: 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-1766-2011: 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-1771-2011: 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-1763-2011: 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-1775-2011: 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-1765-2011: 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-1773-2011: 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-1769-2011: 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-1770-2011: 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-1774-2011: 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-1768-2011: 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-1767-2011: 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 ASRTM Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

Source page: https://510kreport.com/device/K032659
Methodology: https://510kreport.com/methodology