510(k) · Cleared
Recalled · 2010Depuy Asr Modular Acetabular Cup System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Aug 5, 2005 as substantially equivalent to K002883 (DePuy Orthopaedics, Inc., 2000) and 3 other predicates after a 514-day review. Its family tree reaches back 2 generations to 2001. 9 later devices descend from it. It has been recalled 55 times.
- Decided
- Aug 5, 2005
- Review
- 514 days
- Class
- Class III
- Product code
- KWA
- Recalls
- 55
- Predicates
- 4
Its longest line of descent runs back 2 generations to K004043 (2001). 5 ancestors in all, the oldest K965156 (1997). 9 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK004043 Metal Transcend Articulation SystemWrightmedicaltechnologyinc · 2001
- 1 generation backK021349 Metal Transcend Articulation System (Larger Sizes)Wrightmedicaltechnologyinc · 2002
- This deviceK040627 Depuy Asr Modular Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK061423 M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp · 2006
- Descendant · 2 generations on · 2 of its ownK082446 Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc. · 2008 · Recalled
- Descendant · cites it directly · 2 of its ownK062426 Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK073413 Depuy Asr 300 Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2008 · Recalled
- Descendant · cites it directly · 1 of its ownK070359 Depuy Asr Taper Sleeve AdapterDePuy Orthopaedics, Inc. · 2007 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
2006high 3 (2008) · low 0 (2010)2026
Most influential descendants
Showing 5 of 9 · See all- K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp · 2006 · cites it directly3descendants
- K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc. · 2008 · 2 generations on2descendants
- K062426Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2006 · cites it directly2descendants
- K073413Depuy Asr 300 Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2008 · cites it directly1descendant
- K070359Depuy Asr Taper Sleeve AdapterDePuy Orthopaedics, Inc. · 2007 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K004043 | Metal Transcend Articulation System | Wrightmedicaltechnologyinc | 2001 | — |
| −1 | K021349 | Metal Transcend Articulation System (Larger Sizes) | Wrightmedicaltechnologyinc | 2002 | — |
| 0 (this device) | K040627 | Depuy Asr Modular Acetabular Cup System | DePuy Orthopaedics, Inc. | 2005 | — |
| +1 | K061423 | M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads | Biomet Manufacturing Corp | 2006 | — |
| +2 | K082446 | Biomet Metal-on-Metal Hip Systems- Expanded Contraindications | Biomet, Inc. | 2008 | 1 |
| +1 | K062426 | Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K073413 | Depuy Asr 300 Acetabular Cup System | DePuy Orthopaedics, Inc. | 2008 | 36 |
| +1 | K070359 | Depuy Asr Taper Sleeve Adapter | DePuy Orthopaedics, Inc. | 2007 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2012 | 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 KWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002883 | Pinnacle Metal-on-Metal Acetabular Cup LinersSummary page 1…87 KWA SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Pinnacle® Metal-on-Metal Acetabular Cup Line (K002883 & K003523) Wright Medical Metal TRANSCEND® Articulation… | 2000 |
| * | K003523 | Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersSummary page 1…87 KWA SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Pinnacle® Metal-on-Metal Acetabular Cup Line (K002883 & K003523) Wright Medical Metal TRANSCEND® Articulation S… | 2000 |
| * | K021349 | Metal Transcend Articulation System (Larger Sizes)Summary page 1…Line (K002883 & K003523) Wright Medical Metal TRANSCEND® Articulation System (K02 1349) De~uy Ultima® Unipolar Head and Adapter Sleeves… | 2002 |
| * | K965156 | Ultima*Unipolar Head and Adapter SleevesSummary page 1…System (K02 1349) De~uy Ultima® Unipolar Head and Adapter Sleeves (K965 156) DEVICE DESCRIPTION: The DePuy ASRTm Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar… | 1997 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061423 | M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads | 2006 | 3 |
| K062426 | Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners | 2006 | 2 |
| K073413 | Depuy Asr 300 Acetabular Cup System | 2008 | 1 |
| K070359 | Depuy Asr Taper Sleeve Adapter | 2007 | 1 |
| K080991 | Depuy Asr XL Modular Acetabular Cup System | 2008 | 0 |
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-1776-2011 | 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-1791-2011 | 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-1777-2011 | 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-1782-2011 | 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-1759-2011 | 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-1760-2011 | 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-1755-2011 | 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-1750-2011 | 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-1783-2011 | 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-1751-2011 | 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-1784-2011 | 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-1756-2011 | 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-1788-2011 | 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-1779-2011 | 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-1757-2011 | 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-1794-2011 | 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-1787-2011 | 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-1789-2011 | 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-1753-2011 | 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-1780-2011 | 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-1754-2011 | 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-1790-2011 | 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-1749-2011 | 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-1786-2011 | 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-1752-2011 | 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-1762-2011 | 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-1781-2011 | 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-1785-2011 | 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-1758-2011 | 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… |
| Mar 5, 2010 | Not classified | Z-2038-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2057-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2054-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-203-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2046-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2059-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2049-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2058-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2051-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2035-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2050-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2047-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2043-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2040-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2037-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2039-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2056-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2045-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2041-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2044-2010 | Other | 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 sources including national joint replacement… |
| Mar 5, 2010 | Not classified | Z-2048-2010 | Other | 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 sources including national joint replacement… |
The 5 latest of 50 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 4 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K061423 (Biomet Manufacturing Corp, 2006) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K002883.
How does its category compare?
All KWA devicesKWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWA
4in 2012
2007high 11 (2011) · low 0 (2013)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
2007high 167 (2010) · low 57 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
2007high 84 (2010) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 2025
2007high 24,601 (2012) · low 213 (2007)2025
MAUDE reports naming product code KWA, 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 | 8 | 74 | 0 | 213 |
| 2008 | 9 | 57 | 13 | 762 |
| 2009 | 7 | 139 | 0 | 820 |
| 2010 | 6 | 167 | 84 | 3,348 |
| 2011 | 11 | 101 | 28 | 17,737 |
| 2012 | 4 | 76 | 21 | 24,601 |
| 2013 | 0 | — | 1 | 20,020 |
| 2014 | 0 | — | 0 | 16,494 |
| 2015 | 0 | — | 0 | 12,339 |
| 2016 | 0 | — | 1 | 7,872 |
| 2017 | 0 | — | 1 | 6,847 |
| 2018 | 0 | — | 1 | 6,388 |
| 2019 | 0 | — | 2 | 7,628 |
| 2020 | 0 | — | 1 | 4,538 |
| 2021 | 0 | — | 0 | 2,064 |
| 2022 | 0 | — | 0 | 1,617 |
| 2023 | 0 | — | 19 | 1,474 |
| 2024 | 0 | — | 0 | 1,168 |
| 2025 | 0 | — | 0 | 1,216 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040627: Depuy Asr Modular Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040627
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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