510(k) · Cleared
ClearedDepuy M-Spec 36MM Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Orthopaedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 30, 2013 as substantially equivalent to K980513 (DePuy Orthopaedics, Inc., 1998) and 3 other predicates after a 427-day review. Its family tree reaches back 4 generations to 1988. 6 later devices descend from it.
- Decided
- Apr 30, 2013
- Review
- 427 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K883460 (1988). 8 ancestors in all, the oldest K851422 (1985). 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK883460 Focus Total Hip SystemDepuy, Inc. · 1988
- 3 generations backK980513 Articul/Eze Femoral HeadsDePuy Orthopaedics, Inc. · 1998
- 2 generations backK060031 Depuy Modular M HeadsDePuy Orthopaedics, Inc. · 2006
- 1 generation backK082585 Depuy Asphere M-Spec HeadDePuy Orthopaedics, Inc. · 2008
- This deviceK120599 Depuy M-Spec 36MM Femoral HeadsDepuy Orthopaedics · 2013
- Descendant · cites it directly · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- Descendant · 2 generations on · 1 of its ownK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
- Descendant · 2 generations on · 1 of its ownK243977 EMPHASYS Acetabular SystemDepuy Ireland UC · 2025
- Descendant · 3 generations on · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
- Descendant · 3 generations on · 0 of its ownK252067 Velora Acetabular SystemRestor3D, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · cites it directly5descendants
- K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025 · 2 generations on1descendant
- K243977EMPHASYS Acetabular SystemDepuy Ireland UC · 2025 · 2 generations on1descendant
- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 3 generations on0descendants
- K252067Velora Acetabular SystemRestor3D, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K883460 | Focus Total Hip System | Depuy, Inc. | 1988 | — |
| −3 | K980513 | Articul/Eze Femoral Heads | DePuy Orthopaedics, Inc. | 1998 | — |
| −2 | K060031 | Depuy Modular M Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| −1 | K082585 | Depuy Asphere M-Spec Head | DePuy Orthopaedics, Inc. | 2008 | — |
| 0 (this device) | K120599 | Depuy M-Spec 36MM Femoral Heads | Depuy Orthopaedics | 2013 | — |
| +1 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +2 | K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025 | — |
| +2 | K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025 | — |
| +3 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
| +3 | K252067 | Velora Acetabular System | Restor3D, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K980513 | Articul/Eze Femoral HeadsSummary page 1…n 21 CFR 888.3358 and 21 CER 888.3350 Product Code(s) LPH, JDI Legally marketed 36mm Articut'eze Femoral Heads (K9805 13, cleared April 14, 1998) device(s) to which DePuy M-Spec Femoral Heads (K06003 1, cleared January 31, 2006) equiva… | 1998 |
| * | K060031 | Depuy Modular M HeadsSummary page 1…PH, JDI Legally marketed 36mm Articut'eze Femoral Heads (K9805 13, cleared April 14, 1998) device(s) to which DePuy M-Spec Femoral Heads (K06003 1, cleared January 31, 2006) equivalence is claimed DePuy LCS Femoral Hip Prosthesis (K880269, cleared May 6, 1988)… | 2006 |
| * | K880269 | LCS Femoral Hip ProsthesisSummary page 1…98) device(s) to which DePuy M-Spec Femoral Heads (K06003 1, cleared January 31, 2006) equivalence is claimed DePuy LCS Femoral Hip Prosthesis (K880269, cleared May 6, 1988) ____________________DePuy ASphere M-Spec Femoral Heads (K082585, cleared Decemnber 4, 2008)… | 1988 |
| * | K082585 | Depuy Asphere M-Spec HeadSummary page 1…equivalence is claimed DePuy LCS Femoral Hip Prosthesis (K880269, cleared May 6, 1988) ____________________DePuy ASphere M-Spec Femoral Heads (K082585, cleared Decemnber 4, 2008) Reason for 510(k) Line extension submission Device description The sub… | 2008 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | 2024 | 5 |
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 25 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K231873 (Depuy Ireland UC, 2024) has gone furthest, with 5 descendants of its own.
- 11 other devices also cite its predicate K980513.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
Total hip replacement is indicated in the following conditions:
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 or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120599 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120599: Depuy M-Spec 36MM Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120599
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