510(k) Report

510(k) · Cleared

Cleared

Pinnacle Metal-on-Metal Acetabular Cup Liners

K002883510(k) SpecialCleared Oct 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 Oct 13, 2000 after a 28-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.

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

11 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2009: 2 descendants cleared2006: 2 descendants cleared2005: 1 descendant cleared2008: 3 descendants cleared2007: 1 descendant cleared2012: 1 descendant cleared200020052010201520202025
  1. This deviceK002883 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 11 descendants. See all descendants

Descendants cleared per year

2002: 12005: 12006: 22007: 12008: 32009: 22012: 1
2002high 3 (2008) · low 0 (2003)2026

Most influential descendants

Showing 5 of 11 · 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)K002883Pinnacle 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
200210
200510
200620
200710
200830
200920
201210
FIG. 1 — Lineage of K002883, 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), 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 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—DePuy Ultima Metal-On-Metal Acetabular Cup
Named without a submission number
—

What descends from it? (11)

See all 11

4 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
K023786Depuy Pinnacle Metal-on-Metal Acetabular Cup LinerDePuy Orthopaedics, Inc.20021
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—

What is it indicated for?

The Pinnacle Metal-On-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia…

Read the full statement (104 words)

The Pinnacle Metal-On-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previeus.fusion, where bone stock is inadequate for other reconstruction techniques.

The Pinnacle Metal-On-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and 28mm diameter Co-Cr-Mo femoral heads only.

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 KWA

The KWA category page

  • K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012
  • K121544Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113322Conserve Thin ShellWrightmedicaltechnologyinc · 2012
  • K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011

https://510kreport.com/device/K002883 · printed Nov 4, 2026

Cite this page

510(k) Report. “K002883: Pinnacle Metal-on-Metal Acetabular Cup Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002883

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026