510(k) Report

510(k) · Cleared

Cleared

Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene Liner

K010171510(k) TraditionalCleared Apr 6, 200178-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

DePuy Orthopaedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Apr 6, 2001 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 239 later devices descend from it.

Decided
Apr 6, 2001
Review
78 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

239 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2011: 12 descendants cleared2008: 2 descendants cleared2007: 1 descendant cleared2024: 13 descendants cleared2010: 9 descendants cleared2022: 18 descendants cleared2013: 18 descendants cleared2009: 2 descendants cleared2017: 14 descendants cleared2012: 14 descendants cleared2016: 13 descendants cleared2015: 12 descendants cleared2021: 11 descendants cleared2018: 13 descendants cleared2019: 16 descendants cleared2025: 20 descendants cleared2014: 9 descendants cleared2020: 11 descendants cleared2026: 14 descendants cleared2023: 16 descendants cleared200020052010201520202025
  1. This deviceK010171 Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene LinerDePuy Orthopaedics, Inc. · 2001
  2. Descendant · cites it directly · 162 of its ownK022958 Total Hip Femoral Heads and LinersSmith & Nephew, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 149 of its ownK083762 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009
  4. Descendant · 3 generations on · 140 of its ownK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  5. Descendant · 4 generations on · 110 of its ownK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
  6. Descendant · cites it directly · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011

Showing 5 of 239 descendants. See all descendants

Descendants cleared per year

2002: 12007: 12008: 22009: 22010: 92011: 122012: 142013: 182014: 92015: 122016: 132017: 142018: 132019: 162020: 112021: 112022: 182023: 162024: 132025: 202026: 14
2002high 20 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 239 · See all
  • K022958Total Hip Femoral Heads and LinersSmith & Nephew, Inc. · 2002 · cites it directly162descendants
  • K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009 · 2 generations on149descendants
  • K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010 · 3 generations on140descendants
  • K103120Corin Biolox Delta Femoral HeadsCorin USA · 2011 · 4 generations on110descendants
  • K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · cites it directly109descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010171Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene LinerDePuy Orthopaedics, Inc.2001—
+1K022958Total Hip Femoral Heads and LinersSmith & Nephew, Inc.20021
+2K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009—
+3K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010—
+4K103120Corin Biolox Delta Femoral HeadsCorin USA2011—
+1K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200710
200820
200920
201090
2011120
2012140
2013180
201490
2015120
2016130
2017140
2018130
2019160
2020110
2021110
2022180
2023160
2024130
2025200
2026140
FIG. 1 — Lineage of K010171, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (239)

See all 239

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022958Total Hip Femoral Heads and LinersSmith & Nephew, Inc.2002162
K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109
K062489Apex Hcla Acetabular Cup LinersOmnilife Science200763
K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc.200862
K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245

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, K022958 (Smith & Nephew, Inc., 2002) has gone furthest, with 162 descendants of its own.

How does its category compare?

All LPH devices

LPH 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

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K010171 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010171: Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010171

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026