510(k) · Cleared
ClearedDepuy Asphere M-Spec Head
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 Dec 4, 2008 as substantially equivalent to K980513 (DePuy Orthopaedics, Inc., 1998) and 2 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1988. 7 later devices descend from it.
- Decided
- Dec 4, 2008
- Review
- 87 days
- Class
- Class III
- Product code
- KWA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K883460 (1988). 6 ancestors in all, the oldest K851422 (1985). 7 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK883460 Focus Total Hip SystemDepuy, Inc. · 1988
- 2 generations backK980513 Articul/Eze Femoral HeadsDePuy Orthopaedics, Inc. · 1998
- 1 generation backK060031 Depuy Modular M HeadsDePuy Orthopaedics, Inc. · 2006
- This deviceK082585 Depuy Asphere M-Spec HeadDePuy Orthopaedics, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK120599 Depuy M-Spec 36MM Femoral HeadsDepuy Orthopaedics · 2013
- Descendant · 2 generations on · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- Descendant · 3 generations on · 1 of its ownK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
- Descendant · 3 generations on · 1 of its ownK243977 EMPHASYS Acetabular SystemDepuy Ireland UC · 2025
- Descendant · 4 generations on · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K120599Depuy M-Spec 36MM Femoral HeadsDepuy Orthopaedics · 2013 · cites it directly6descendants
- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · 2 generations on5descendants
- K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025 · 3 generations on1descendant
- K243977EMPHASYS Acetabular SystemDepuy Ireland UC · 2025 · 3 generations on1descendant
- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883460 | Focus Total Hip System | Depuy, Inc. | 1988 | — |
| −2 | K980513 | Articul/Eze Femoral Heads | DePuy Orthopaedics, Inc. | 1998 | — |
| −1 | K060031 | Depuy Modular M Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| 0 (this device) | K082585 | Depuy Asphere M-Spec Head | DePuy Orthopaedics, Inc. | 2008 | — |
| +1 | K120599 | Depuy M-Spec 36MM Femoral Heads | Depuy Orthopaedics | 2013 | — |
| +2 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +3 | K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025 | — |
| +3 | K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025 | — |
| +4 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980513 | Articul/Eze Femoral HeadsSummary page 1…uct Codes: 87 KWA, 87 JDI, and 87 LPH Substantially Eguivalent DePuy M-Spec Head Devices: 36 mm: K9805 13 and internal documentation to K85 1422 40 m… | 1998 |
| * | K851422 | S-Rom 135 Femoral Stem & Collar (Part of S-Rom HipSummary page 1…t DePuy M-Spec Head Devices: 36 mm: K9805 13 and internal documentation to K85 1422 40 mm and 44 mm: K060031… | 1985 |
| * | K060031 | Depuy Modular M HeadsSummary page 1…36 mm: K9805 13 and internal documentation to K85 1422 40 mm and 44 mm: K060031 z2/' Device Description: The aSphere M-Spec Hea… | 2006 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120599 | Depuy M-Spec 36MM Femoral Heads | 2013 | 6 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K120599 (Depuy Orthopaedics, 2013) has gone furthest, with 6 descendants of its own.
- 11 other devices also cite its predicate K980513.
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
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 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 aSphere M-Spec Head is indicated for use in the treatment of:
1. A severely painful and/or a severely disabled joint resulting from osteoarthritis,
traumatic arthritis, or rheumatoid arthritis, or congenital'hip dysplasia;
2. Avascular ftecrosis of the femoral head;
3. Acute traumatic fracture of the femoral head or neck;
4. Failed previous surgery, including joint reconstruction, internal fixation,
arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip
replacement; and
5. Certain cases of ankylosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082585 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082585: Depuy Asphere M-Spec Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082585
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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