510(k) Report

510(k) · Cleared

Cleared

Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners

K003523510(k) SpecialCleared Dec 13, 200028-day reviewClass III21 CFR 888.3330

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

DePuy Orthopaedics, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Dec 13, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.

Decided
Dec 13, 2000
Review
28 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
0

10 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2006: 2 descendants cleared2005: 1 descendant cleared2008: 3 descendants cleared2007: 1 descendant cleared2012: 1 descendant cleared200020052010201520202025
  1. This deviceK003523 Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2000
  2. Descendant · cites it directly · 9 of its ownK040627 Depuy Asr Modular Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2005 · Recalled
  3. Descendant · 2 generations on · 3 of its ownK061423 M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp · 2006
  4. Descendant · 3 generations on · 2 of its ownK082446 Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc. · 2008 · Recalled
  5. Descendant · cites it directly · 2 of its ownK062426 Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2006
  6. Descendant · 2 generations on · 1 of its ownK073413 Depuy Asr 300 Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2008 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22007: 12008: 32009: 22012: 1
2005high 3 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 10 · See all
  • K040627Depuy Asr Modular Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2005 · cites it directly9descendants
  • K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp · 2006 · 2 generations on3descendants
  • K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc. · 2008 · 3 generations on2descendants
  • K062426Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2006 · cites it directly2descendants
  • K073413Depuy Asr 300 Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2008 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003523Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.2000—
+1K040627Depuy Asr Modular Acetabular Cup SystemDePuy Orthopaedics, Inc.200555
+2K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp2006—
+3K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.20081
+1K062426Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.2006—
+2K073413Depuy Asr 300 Acetabular Cup SystemDePuy Orthopaedics, Inc.200836

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200710
200830
200920
201210
FIG. 1 — Lineage of K003523, 2000–2012Source: 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 KWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (10)

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

NumberDeviceApplicantDecidedDescendants
K040627Depuy Asr Modular Acetabular Cup SystemDePuy Orthopaedics, Inc.20059
K062426Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20062
K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090

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, K040627 (DePuy Orthopaedics, Inc., 2005) has gone furthest, with 9 descendants of its own.

How does its category compare?

All KWA devices

KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWA

4in 2012

2007: 82008: 92009: 72010: 62011: 112012: 4
2007high 11 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWA

76in 2012

2007: 74 days median2008: 57 days median2009: 139 days median2010: 167 days median2011: 101 days median2012: 76 days median
2007high 167 (2010) · low 57 (2008)2026

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

Recalls per year · KWA

19in 2023

2008: 132010: 842011: 282012: 212013: 12016: 12017: 12018: 12019: 22020: 12023: 19
2007high 84 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWA

1,216in 2025

2007: 2132008: 7622009: 8202010: 3,3482011: 17,7372012: 24,6012013: 20,0202014: 16,4942015: 12,3392016: 7,8722017: 6,8472018: 6,3882019: 7,6282020: 4,5382021: 2,0642022: 1,6172023: 1,4742024: 1,1682025: 1,216
2007high 24,601 (2012) · low 213 (2007)2025

MAUDE reports naming product code KWA, 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
20078740213
200895713762
200971390820
20106167843,348
2011111012817,737
20124762124,601
20130—120,020
20140—016,494
20150—012,339
20160—17,872
20170—16,847
20180—16,388
20190—27,628
20200—14,538
20210—02,064
20220—01,617
20230—191,474
20240—01,168
20250—01,216
20260—0—

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 KWA

The KWA category page

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  • K121544Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
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  • K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011

https://510kreport.com/device/K003523 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003523: Depuy Pinnacle Metal-on-Metal 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/K003523

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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