510(k) · Cleared
Recalled · 2010Depuy Asr Resurfacing Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · KXA Prosthesis, Hip, Femoral, Resurfacing
Cleared on Dec 4, 2003 as substantially equivalent to K021799 (Biomet Orthopedics, Inc., 2002) after a 98-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it. It has been recalled 13 times.
- Decided
- Dec 4, 2003
- Review
- 98 days
- Class
- Class II
- Product code
- KXA
- Recalls
- 13
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983452 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK983452 Nelson Resurfacing HeadBiomet, Inc. · 1998
- 1 generation backK021799 Cemented Femoral Head Resurfing DeviceBiomet Orthopedics, Inc. · 2002
- This deviceK032659 Depuy Asr Resurfacing Femoral HeadsDePuy Orthopaedics, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK043542 Biopro Tara Femoral Resurfacing ComponentBiopro, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK070292 Durom Hip Resurfacing System, Femoral ComponentsZimmer GmbH · 2007 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983452 | Nelson Resurfacing Head | Biomet, Inc. | 1998 | — |
| −1 | K021799 | Cemented Femoral Head Resurfing Device | Biomet Orthopedics, Inc. | 2002 | — |
| 0 (this device) | K032659 | Depuy Asr Resurfacing Femoral Heads | DePuy Orthopaedics, Inc. | 2003 | — |
| +1 | K043542 | Biopro Tara Femoral Resurfacing Component | Biopro, Inc. | 2005 | — |
| +1 | K070292 | Durom Hip Resurfacing System, Femoral Components | Zimmer GmbH | 2007 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KXA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KXA device
- #1 K201219 Biocore9 Femoral Head Resurfacing Componentscore 0.7 · 1 generation · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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…Class I! DEVICE PRODUCT CODE: 87 KXA SUBSTANTIALLY EQUIVALENT DePuy '.A.R.A Total Hip, K810325 DEVICES: Cemented Femoral Head Resurfacing Device… | |
| * | K021799 | Cemented Femoral Head Resurfing DeviceSummary page 1…K810325 DEVICES: Cemented Femoral Head Resurfacing Device (Biomet Orthopaedics, Inc.), K021799 DEVICE DESCRIPTION: The DePuy ASRTM Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2010 | Not classified | Z-1772-2011 | Device Design | 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, company sponsored clinical trials… |
| Aug 23, 2010 | Not classified | Z-1764-2011 | Device Design | 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, company sponsored clinical trials… |
| Aug 23, 2010 | Not classified | Z-1766-2011 | Device Design | 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, company sponsored clinical trials… |
| Aug 23, 2010 | Not classified | Z-1771-2011 | Device Design | 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, company sponsored clinical trials… |
| Aug 23, 2010 | Not classified | Z-1763-2011 | Device Design | 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, company sponsored clinical trials… |
| Aug 23, 2010 | Not classified | Z-1775-2011 | Device Design | 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, company sponsored clinical trials… |
| Aug 23, 2010 | Not classified | Z-1765-2011 | Device Design | 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, company sponsored clinical trials… |
| Aug 23, 2010 | Not classified | Z-1773-2011 | Device Design | 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, company sponsored clinical trials… |
| Aug 23, 2010 | Not classified | Z-1769-2011 | Device Design | 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, company sponsored clinical trials… |
| Aug 23, 2010 | Not classified | Z-1770-2011 | Device Design | 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, company sponsored clinical trials… |
| Aug 23, 2010 | Not classified | Z-1774-2011 | Device Design | 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, company sponsored clinical trials… |
| Aug 23, 2010 | Not classified | Z-1768-2011 | Device Design | 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, company sponsored clinical trials… |
| Aug 23, 2010 | Not classified | Z-1767-2011 | Device Design | 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, company sponsored clinical trials… |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K043542 (Biopro, Inc., 2005) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K021799.
How does its category compare?
All KXA devicesKXA Prosthesis, Hip, Femoral, Resurfacing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXA
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KXA
Too few KXA 510(k)s in any year since 2007 to give a median.
Recalls per year · KXA
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXA
14in 2025
MAUDE reports naming product code KXA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 2 | 15 |
| 2008 | 1 | — | 0 | 22 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 1 | — | 13 | 68 |
| 2011 | 0 | — | 0 | 593 |
| 2012 | 0 | — | 1 | 2,099 |
| 2013 | 0 | — | 0 | 2,522 |
| 2014 | 0 | — | 0 | 2,431 |
| 2015 | 0 | — | 0 | 1,674 |
| 2016 | 0 | — | 0 | 621 |
| 2017 | 0 | — | 0 | 580 |
| 2018 | 0 | — | 0 | 430 |
| 2019 | 0 | — | 0 | 971 |
| 2020 | 0 | — | 0 | 373 |
| 2021 | 1 | — | 0 | 17 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032659: Depuy Asr Resurfacing Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032659
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026