510(k) Report

510(k) · Cleared

Cleared

Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners

K083642510(k) TraditionalCleared Mar 6, 200987-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 Mar 6, 2009 as substantially equivalent to K062426 (DePuy Orthopaedics, Inc., 2006) and 4 other predicates after an 87-day review. Its family tree reaches back 6 generations to 1988.

Decided
Mar 6, 2009
Review
87 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K881288 (1988). 50 ancestors in all, the oldest K830313 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 2 other ancestors2002: 3 other ancestors2000: 7 other ancestors2005: 2 other ancestors2001: 2 other ancestors2003: 3 other ancestors1997: 4 other ancestors1996: 4 other ancestors1994: 6 other ancestors1983: 1 other ancestor1999: 2 other ancestors1998: 2 other ancestors1995: 2 other ancestors1985: 2 other ancestors1991: 1 other ancestor1986: 1 other ancestorK881288 · Corin Modular Moore Stem · Orthopedic Systems, Inc. · 1988K960538 · Opteon Unipolar · Exactech, Inc. · 1996K984028 · The New Bio-Moore Endo Heads · Biomet, Inc. · 1999K042037 · M2A Magnum System · Biomet, Inc. · 2004K061423 · M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads · Biomet Manufacturing Corp · 2006K082446 · Biomet Metal-on-Metal Hip Systems- Expanded Contraindications · Biomet, Inc. · 2008 · recalled1980198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 7 other ancestors3 generations back: 9 other ancestors4 generations back: 11 other ancestors5 generations back: 13 other ancestors K082446 · Biomet Metal-on-Metal Hip Systems- Expanded Contraindications · Biomet, Inc. · 2008 · recalledK061423 · M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads · Biomet Manufacturing Corp · 2006K042037 · M2A Magnum System · Biomet, Inc. · 2004K984028 · The New Bio-Moore Endo Heads · Biomet, Inc. · 1999K960538 · Opteon Unipolar · Exactech, Inc. · 1996K881288 · Corin Modular Moore Stem · Orthopedic Systems, Inc. · 1988−50
  1. Root · 6 generations backK881288 Corin Modular Moore StemOrthopedic Systems, Inc. · 1988
  2. 5 generations backK960538 Opteon UnipolarExactech, Inc. · 1996
  3. 4 generations backK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
  4. 3 generations backK042037 M2A Magnum SystemBiomet, Inc. · 2004
  5. 2 generations backK061423 M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp · 2006
  6. 1 generation backK082446 Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc. · 2008 · Recalled
  7. This deviceK083642 Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K881288Corin Modular Moore StemOrthopedic Systems, Inc.1988—
−5K960538Opteon UnipolarExactech, Inc.1996—
−4K984028The New Bio-Moore Endo HeadsBiomet, Inc.1999—
−3K042037M2A Magnum SystemBiomet, Inc.2004—
−2K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp2006—
−1K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.20081
0 (this device)K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198520
198610
199110
199460
199520
199640
199740
199820
199920
200070
200120
200230
200330
200520
200620
FIG. 1 — Lineage of K083642, 1988–2009Source: 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? (5)

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
*K062426Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners
Summary page 1
…PRODUCT CODE: 87 KWA SUBSTANTIALLY EQUIVALENT DePuy Pinnacle® Metal-on-Metal Acetabular Cup DEVICE(S): Liners, K062426 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners,…
DePuy Orthopaedics, Inc.2006—
*K023786Depuy Pinnacle Metal-on-Metal Acetabular Cup Liner
Summary page 1
…Liners, K062426 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K023786 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners,…
DePuy Orthopaedics, Inc.2002—
*K003523Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners
Summary page 1
…Liners, K023786 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K003523 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners,…
DePuy Orthopaedics, Inc.2000—
*K002883Pinnacle Metal-on-Metal Acetabular Cup Liners
Summary page 1
…Liners, K003523 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K002883 Biomet® Metal-on-Metal Hip Systems, K082446…
DePuy Orthopaedics, Inc.2000—
*K082446Biomet Metal-on-Metal Hip Systems- Expanded Contraindications
Summary page 1
…y Pinnacle® Metal-on-Metal Acetabular Cup Liners, K002883 Biomet® Metal-on-Metal Hip Systems, K082446 00010…
Biomet, Inc.20081

Also cleared against K062426: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
  • 4 of the 50 ancestors have a recall of any class.
  • 1 other device also cites its predicate K062426.

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. 2009, this device’s year, is highlighted.

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 fernoral 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 fernoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous 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 M-Spec Co-Cr-Mo femoral heads only.

Indications for use as stated in the FDA summary.

Also cleared against K062426

1 other device cites the same predicate.

  • K091973Metasul Taper Liners, Metasul Femoral HeadsZimmer GmbH · 20094 recalls

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/K083642 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083642: 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/K083642

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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