510(k) · Cleared
Recalled · 2010Depuy Asr 300 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 Jan 30, 2008 as substantially equivalent to K040627 (DePuy Orthopaedics, Inc., 2005) and 1 other predicate after a 57-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it. It has been recalled 36 times.
- Decided
- Jan 30, 2008
- Review
- 57 days
- Class
- Class III
- Product code
- KWA
- Recalls
- 36
- Predicates
- 3
Its longest line of descent runs back 3 generations to K930712 (1993). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 2 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 1 generation backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- This deviceK073413 Depuy Asr 300 Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK080991 Depuy Asr XL Modular Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2008 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K080991Depuy Asr XL Modular Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −2 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −1 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| 0 (this device) | K073413 | Depuy Asr 300 Acetabular Cup System | DePuy Orthopaedics, Inc. | 2008 | — |
| +1 | K080991 | Depuy Asr XL Modular Acetabular Cup System | DePuy Orthopaedics, Inc. | 2008 | 41 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K040627 | Depuy Asr Modular Acetabular Cup SystemSummary page 1…sis DEVICE PRODUCT CODE: 87 KWA SUBSTANTIALLY EQUIVALENT DePuy ASRTM Modular Acetabular Cup System, DEVICE: K040627 DePuy Pinnacle® Acetabular Cup System, K000306… | 2005 |
| * | K000306 | Pinnacle Acetabular SystemSummary page 1…System, DEVICE: K040627 DePuy Pinnacle® Acetabular Cup System, K000306 Porocoat Lunceford Acetabulum, K823145 $,0… | 2000 |
| Kept off the family tree | K823145 | Porocoat Lunceford Acetabulum 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…DePuy Pinnacle® Acetabular Cup System, K000306 Porocoat Lunceford Acetabulum, K823145 $,0739i-3 (2. DEVICE DESCRIPTION: The subject DePuy ASRTM 300 Acetabular Cup S… |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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-1803-2011 | 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-1799-2011 | 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-1798-2011 | 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-1796-2011 | 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-1802-2011 | 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-1801-2011 | 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-1795-2011 | 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-1804-2011 | 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-1800-2011 | 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-1797-2011 | 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-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-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-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 36 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 15 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K080991 (DePuy Orthopaedics, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 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 device 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.
Porous-coated ASR 300 Acetabular Cups are indicated for cementless application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073413 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073413: Depuy Asr 300 Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073413
Report an extraction error
Are you the manufacturer?
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