510(k) Report

510(k) · Cleared

Cleared

Depuy Duraloc Acetabular Cup System-Enduron Liner

K983491510(k) TraditionalCleared Dec 2, 199858-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 Dec 2, 1998 as substantially equivalent to K900832 (Depuy, Inc., 1990) and 2 other predicates after a 58-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided
Dec 2, 1998
Review
58 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K900891 (1990). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1990: 1 other ancestor2020: 1 descendant clearedK900891 · Modified Aml + Acetabular Cup Prosthesis · Depuy, Inc. · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K900891 · Modified Aml + Acetabular Cup Prosthesis · Depuy, Inc. · 19900
  1. Root · 1 generation backK900891 Modified Aml + Acetabular Cup ProsthesisDepuy, Inc. · 1990
  2. This deviceK983491 Depuy Duraloc Acetabular Cup System-Enduron LinerDePuy Orthopaedics, Inc. · 1998
  3. Descendant · cites it directly · 0 of its ownK191826 KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K900891Modified Aml + Acetabular Cup ProsthesisDepuy, Inc.1990—
0 (this device)K983491Depuy Duraloc Acetabular Cup System-Enduron LinerDePuy Orthopaedics, Inc.1998—
+1K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K983491, 1990–2020Source: 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), 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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K900832Modified Depuy Acetabular Cup System* Hip Aceta.
Summary page 1
…p joint metal/polymer semi-constrained cementless prosthesis DEVICE PRODUCT CODE: 87 LPH and JDM SUBSTANTIALLY EQUIVALENT DEVICE: Modified DePuy Acetabular Cup System (K900832) Modified AML® + Acetabular Cup Prosthesis (K900891) DePuy Duraloc® Cementless Acetabular Cup System (K961186) DEVICE DESCRIPTIO…
Depuy, Inc.1990—
*K900891Modified Aml + Acetabular Cup Prosthesis
Summary page 1
…rosthesis DEVICE PRODUCT CODE: 87 LPH and JDM SUBSTANTIALLY EQUIVALENT DEVICE: Modified DePuy Acetabular Cup System (K900832) Modified AML® + Acetabular Cup Prosthesis (K900891) DePuy Duraloc® Cementless Acetabular Cup System (K961186) DEVICE DESCRIPTION AND INTENDED USE: The DePuy Duraloc Acetabular Li…
Depuy, Inc.1990—
*K961186Depuy Duraloc Cementless Acetabular Cup System
Summary page 1
…LY EQUIVALENT DEVICE: Modified DePuy Acetabular Cup System (K900832) Modified AML® + Acetabular Cup Prosthesis (K900891) DePuy Duraloc® Cementless Acetabular Cup System (K961186) DEVICE DESCRIPTION AND INTENDED USE: The DePuy Duraloc Acetabular Liners are manufactured from ultra high molecular weight pol…
Depuy, Inc.1996—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K191826 (Beijing Keyi Medical Device Technology Co., Ltd., 2020) has gone furthest, with 0 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—

What is it indicated for?

The DePuy Duraloc Acetabular Cup Liners are to be used with the DePuy Duraloc Acetabular Cup System’s metal acetabular shells 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.

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/K983491 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983491: Depuy Duraloc Acetabular Cup System-Enduron Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983491

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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