510(k) · Cleared
ClearedDepuy Modular M Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jan 31, 2006 as substantially equivalent to K033273 (DePuy Orthopaedics, Inc., 2004) and 2 other predicates after a 26-day review. Its family tree reaches back 2 generations to 1988. 18 later devices descend from it.
- Decided
- Jan 31, 2006
- Review
- 26 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K883460 (1988). 5 ancestors in all, the oldest K851422 (1985). 18 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK883460 Focus Total Hip SystemDepuy, Inc. · 1988
- 1 generation backK980513 Articul/Eze Femoral HeadsDePuy Orthopaedics, Inc. · 1998
- This deviceK060031 Depuy Modular M HeadsDePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK082585 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 · cites it directly · 6 of its ownK071117 Modification to Pinnacle Constrained Acetabular LinersDePuy Orthopaedics, Inc. · 2007 · Recalled
- 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 · 4 of its ownK153131 Logical C-Series Acetabular Shell, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd. · 2016
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K082585Depuy Asphere M-Spec HeadDePuy Orthopaedics, Inc. · 2008 · cites it directly7descendants
- K120599Depuy M-Spec 36MM Femoral HeadsDepuy Orthopaedics · 2013 · cites it directly6descendants
- K071117Modification to Pinnacle Constrained Acetabular LinersDePuy Orthopaedics, Inc. · 2007 · cites it directly6descendants
- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · cites it directly5descendants
- K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd. · 2016 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883460 | Focus Total Hip System | Depuy, Inc. | 1988 | — |
| −1 | K980513 | Articul/Eze Femoral Heads | DePuy Orthopaedics, Inc. | 1998 | — |
| 0 (this device) | K060031 | Depuy Modular M Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K082585 | Depuy Asphere M-Spec Head | DePuy Orthopaedics, Inc. | 2008 | — |
| +1 | K120599 | Depuy M-Spec 36MM Femoral Heads | Depuy Orthopaedics | 2013 | — |
| +1 | K071117 | Modification to Pinnacle Constrained Acetabular Liners | DePuy Orthopaedics, Inc. | 2007 | 1 |
| +1 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +2 | K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical… | Signature Orthopaedics Pty, Ltd. | 2016 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K033273 | Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima…Summary page 1…SUBSTANTIALLY EQUIVALENT DEVICES: Tm * Del'uy IJLTIMA Unipolar Femoral Heads: K033273 (submitted as Pinnacle' Acetabular System) * DePuy Articul/eze Femoral Heads: K980513 * DePuy 36 mm Femora… | 2004 |
| * | K980513 | Articul/Eze Femoral HeadsSummary page 1…Tm * Del'uy IJLTIMA Unipolar Femoral Heads: K033273 (submitted as Pinnacle' Acetabular System) * DePuy Articul/eze Femoral Heads: K980513 * DePuy 36 mm Femoral Heads: K980513, K85 1422 (cleared through internal documentation.) DEVICE DESCRIPTION AND… | 1998 |
| * | K851422 | S-Rom 135 Femoral Stem & Collar (Part of S-Rom HipSummary page 1…Femoral Heads: K033273 (submitted as Pinnacle' Acetabular System) * DePuy Articul/eze Femoral Heads: K980513 * DePuy 36 mm Femoral Heads: K980513, K85 1422 (cleared through internal documentation.) DEVICE DESCRIPTION AND INTENDED USE: The subject DePuy Modular M Heads a… | 1985 |
What descends from it? (18)
See all 185 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082585 | Depuy Asphere M-Spec Head | 2008 | 7 |
| K120599 | Depuy M-Spec 36MM Femoral Heads | 2013 | 6 |
| K071117 | Modification to Pinnacle Constrained Acetabular Liners | 2007 | 6 |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | 2024 | 5 |
| K160895 | Initia Total Hip System & BIOCERAM AZUL (R) HEAD | 2016 | 2 |
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 18 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K082585 (DePuy Orthopaedics, Inc., 2008) has gone furthest, with 7 descendants of its own.
- 9 other devices also cite its predicate K033273.
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.
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?
DePuy Modular M Heads are indicated for use in total hip replacement procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic…
Read the full statement (133 words)
DePuy Modular M Heads are indicated for use in total hip replacement procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. 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.
The DePuy Modular M Heads are indicated for use with the Pinnacle® Acetabular Cup in cementless application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060031 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060031: Depuy Modular M Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060031
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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