510(k) · Cleared
Recalled · 2010Depuy Asr XL 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 Jul 2, 2008 as substantially equivalent to K040627 (DePuy Orthopaedics, Inc., 2005) and 6 other predicates after an 86-day review. Its family tree reaches back 6 generations to 1994. It has been recalled 41 times.
- Decided
- Jul 2, 2008
- Review
- 86 days
- Class
- Class III
- Product code
- KWA
- Recalls
- 41
- Predicates
- 7
Its longest line of descent runs back 6 generations to K935452 (1994). 32 ancestors in all, the oldest K851422 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 5 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 4 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- 3 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- 2 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- 1 generation backK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- This deviceK080991 Depuy Asr XL Modular Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −5 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −4 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −3 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −2 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| 0 (this device) | K080991 | Depuy Asr XL Modular Acetabular Cup System | DePuy Orthopaedics, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | K040627 | Depuy Asr Modular Acetabular Cup SystemSummary page 1…E(S): 87 KWA SUBSTANTIALLY EQUIVALENT DePuy ASR TM Modular Acetabular Cup System DEVICE(S): (K040627) DePuy ASRTM 300 Acetabular Cup System… | 2005 |
| * | K073413 | Depuy Asr 300 Acetabular Cup SystemSummary page 1…(K040627) DePuy ASRTM 300 Acetabular Cup System (K073413) Wright Medical Metal TRANSCEND® Arti… | 2008 |
| * | K021349 | Metal Transcend Articulation System (Larger Sizes)Summary page 1…Wright Medical Metal TRANSCEND® Articulation System (Larger Sizes) (K021349) DePuy Ultima® Unipolar Head and Adapter… | 2002 |
| * | K965156 | Ultima*Unipolar Head and Adapter SleevesSummary page 1…(K021349) DePuy Ultima® Unipolar Head and Adapter Sleeves (K965156) DePuy ASR TM Taper Sleeve Adapter (K0703 59)… | 1997 |
| * | K070359 | Depuy Asr Taper Sleeve AdapterSummary page 1…nipolar Head and Adapter Sleeves (K965156) DePuy ASR TM Taper Sleeve Adapter (K0703 59) Corail AMT H~ Prosthesis (K042992)… | 2007 |
| * | K042992 | Corail Amt Hip ProsthesisSummary page 1…65156) DePuy ASR TM Taper Sleeve Adapter (K0703 59) Corail AMT H~ Prosthesis (K042992) M T… | 2005 |
| * | K073570 | Depuy Tri-Lock Bone Preservation StemSummary page 1…T DePuy Tri-Lock Bone Preservation Stem (K073570) Page 15 of 152 DePuy ASR XL Modular Acetabular Cup System DEVI… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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-1811-2011 | 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-1814-2011 | 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-1815-2011 | 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-1807-2011 | 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-1812-2011 | 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-1808-2011 | 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-1810-2011 | 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-1816-2011 | 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-1806-2011 | 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-1809-2011 | 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-1805-2011 | 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-1813-2011 | 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-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… |
| Mar 5, 2010 | Not classified | Z-2033-2010 | 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-2055-2010 | 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-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-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-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-2053-2010 | 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-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-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-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-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-2031-2010 | 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-2042-2010 | 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-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-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-2032-2010 | 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-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-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-2052-2010 | 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-2036-2010 | 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 41 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 14 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 32 ancestors have a recall of any class.
- 4 other devices also cite its predicate K040627.
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. 2008, this device’s year, is highlighted.
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 XL Modular Acetabular Cup System is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head and neck.
4. Failed previous hip surgery, including internal fixation, arthrodesis and hemi-arthroplasty.
5. Certain cases of ankylosis.
Porous-coated DePuy ASR XL Modular Acetabular Cups are indicated for cementless application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080991: Depuy Asr XL 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/K080991
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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