510(k) · Cleared
ClearedDepuy Duraloc Acetabular Cup System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 12, 1997 after a 124-day review. The FDA summary names its predicate without a number. 198 later devices descend from it.
- Decided
- Nov 12, 1997
- Review
- 124 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
198 later devices descend from it, 3 citing it directly.
- This deviceK972596 Depuy Duraloc Acetabular Cup SystemDepuy, Inc. · 1997
- Descendant · cites it directly · 194 of its ownK994415 Marathon Cross-Linked Polyethylene Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2000
- Descendant · 2 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- Descendant · 2 generations on · 63 of its ownK062489 Apex Hcla Acetabular Cup LinersOmnilife Science · 2007
- Descendant · 3 generations on · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
- Descendant · 2 generations on · 62 of its ownK073150 Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008
Showing 5 of 198 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 198 · See all- K994415Marathon Cross-Linked Polyethylene Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2000 · cites it directly194descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 2 generations on109descendants
- K062489Apex Hcla Acetabular Cup LinersOmnilife Science · 2007 · 2 generations on63descendants
- K111911Corin Optimom Modular HeadCorin USA · 2011 · 3 generations on62descendants
- K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008 · 2 generations on62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972596 | Depuy Duraloc Acetabular Cup System | Depuy, Inc. | 1997 | — |
| +1 | K994415 | Marathon Cross-Linked Polyethylene Acetabular Cup Liners | DePuy Orthopaedics, Inc. | 2000 | — |
| +2 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| +2 | K062489 | Apex Hcla Acetabular Cup Liners | Omnilife Science | 2007 | — |
| +3 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| +2 | K073150 | Apex-LNK Poly Acetabular Cup Liners | Omni Life Science, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 8 | 0 |
| 2011 | 7 | 0 |
| 2012 | 13 | 0 |
| 2013 | 14 | 0 |
| 2014 | 6 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 13 | 0 |
| 2019 | 13 | 0 |
| 2020 | 11 | 0 |
| 2021 | 10 | 0 |
| 2022 | 13 | 0 |
| 2023 | 14 | 0 |
| 2024 | 10 | 0 |
| 2025 | 19 | 0 |
| 2026 | 14 | 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? (2)
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 |
|---|---|---|---|
| * | — | Modified DePuy Acetabular Cup System Named without a submission number | |
| * | — | DePuy Modified AML+ Acetabular Cup System Named without a submission number |
What descends from it? (198)
See all 1983 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K994415 (DePuy Orthopaedics, Inc., 2000) has gone furthest, with 194 descendants of its own.
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?
The DePuy Duraloc Acetabular Cup Liners are intended to be used with the Duraloc System Acetabular Cups to resurface the acetabular socket in cemented or cementless total hip arthroplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972596 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972596: Depuy Duraloc Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972596
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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