510(k) · Cleared
ClearedMarathon Cross-Linked Polyethylene Acetabular Cup Liners
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 Feb 3, 2000 as substantially equivalent to K972596 (Depuy, Inc., 1997) after a 36-day review. Its family tree reaches back 1 generation to 1997. 194 later devices descend from it.
- Decided
- Feb 3, 2000
- Review
- 36 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972596 (1997). 194 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK972596 Depuy Duraloc Acetabular Cup SystemDepuy, Inc. · 1997
- This deviceK994415 Marathon Cross-Linked Polyethylene Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2000
- Descendant · cites it directly · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- Descendant · cites it directly · 63 of its ownK062489 Apex Hcla Acetabular Cup LinersOmnilife Science · 2007
- Descendant · 2 generations on · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
- Descendant · cites it directly · 62 of its ownK073150 Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008
- Descendant · 3 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
Showing 5 of 194 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 194 · See all- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · cites it directly109descendants
- K062489Apex Hcla Acetabular Cup LinersOmnilife Science · 2007 · cites it directly63descendants
- K111911Corin Optimom Modular HeadCorin USA · 2011 · 2 generations on62descendants
- K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008 · cites it directly62descendants
- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 3 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972596 | Depuy Duraloc Acetabular Cup System | Depuy, Inc. | 1997 | — |
| 0 (this device) | K994415 | Marathon Cross-Linked Polyethylene Acetabular Cup Liners | DePuy Orthopaedics, Inc. | 2000 | — |
| +1 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| +1 | K062489 | Apex Hcla Acetabular Cup Liners | Omnilife Science | 2007 | — |
| +2 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| +1 | K073150 | Apex-LNK Poly Acetabular Cup Liners | Omni Life Science, Inc. | 2008 | — |
| +3 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 8 | 0 |
| 2017 | 9 | 0 |
| 2018 | 13 | 0 |
| 2019 | 13 | 0 |
| 2020 | 11 | 0 |
| 2021 | 10 | 0 |
| 2022 | 13 | 0 |
| 2023 | 13 | 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? (1)
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 |
|---|---|---|---|
| * | K972596 | Depuy Duraloc Acetabular Cup SystemSummary page 1…SUBSTANTIAL EQUIVALENCE: The Marathon Cross-linked Polyethylene Acetabular Cup Liners have the following similarities to the acetabular cup liners that were cleared in K972596: same intended use; same material; same method of manufacture; same design; same mating components; same sterilization and packag… | 1997 |
What descends from it? (194)
See all 1947 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110087 | Corin Trinity Acetbular System with Hxlpe Liners | 2011 | 109 |
| K062489 | Apex Hcla Acetabular Cup Liners | 2007 | 63 |
| K073150 | Apex-LNK Poly Acetabular Cup Liners | 2008 | 62 |
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular Insert | 2007 | 38 |
| K100933 | Consensus CS2 Plus Acetabular Insert | 2010 | 35 |
| K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | 2010 | 23 |
| 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?
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 Marathon Cross-linked Polyethylene 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/K994415 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994415: Marathon Cross-Linked Polyethylene Acetabular Cup Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994415
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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