510(k) · Cleared
ClearedDepuy Pinnacle Metal-on-Metal Acetabular Cup Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Dec 15, 2006 as substantially equivalent to K003523 (DePuy Orthopaedics, Inc., 2000) and 2 other predicates after a 119-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 15, 2006
- Review
- 119 days
- Class
- Class III
- Product code
- KWA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K004043 (2001). 6 ancestors in all, the oldest K965156 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK004043 Metal Transcend Articulation SystemWrightmedicaltechnologyinc · 2001
- 2 generations backK021349 Metal Transcend Articulation System (Larger Sizes)Wrightmedicaltechnologyinc · 2002
- 1 generation backK040627 Depuy Asr Modular Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2005 · Recalled
- This deviceK062426 Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK091973 Metasul Taper Liners, Metasul Femoral HeadsZimmer GmbH · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK083642 Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K004043 | Metal Transcend Articulation System | Wrightmedicaltechnologyinc | 2001 | — |
| −2 | K021349 | Metal Transcend Articulation System (Larger Sizes) | Wrightmedicaltechnologyinc | 2002 | — |
| −1 | K040627 | Depuy Asr Modular Acetabular Cup System | DePuy Orthopaedics, Inc. | 2005 | 55 |
| 0 (this device) | K062426 | Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K091973 | Metasul Taper Liners, Metasul Femoral Heads | Zimmer GmbH | 2009 | 4 |
| +1 | K083642 | Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners | DePuy Orthopaedics, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003523 | Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersSummary page 1…UBSTANTIALLY EQUIVALENT DEVICE(S): DePuy Pinnacle 36mm Metal-On-Metal Acetabular Cup Liners (K003523, cleared December 13, 2000) DePuy Pinnacle Metal-On-Metal Acetabular Cup… | 2000 |
| * | K002883 | Pinnacle Metal-on-Metal Acetabular Cup LinersSummary page 1…cleared December 13, 2000) DePuy Pinnacle Metal-On-Metal Acetabular Cup Liners (K002883, cleared Ocotober 13, 2000) DePuy ASR Modular Acetabular Cup System… | 2000 |
| * | K040627 | Depuy Asr Modular Acetabular Cup SystemSummary page 1…ners (K002883, cleared Ocotober 13, 2000) DePuy ASR Modular Acetabular Cup System (K040627, cleared August 5, 2005) DEVICE INFORMATION: A. DEVICE DESCRIPTION The Pinnacle Metal-On-Metal (MOM) Acetabular Cup Liner… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K091973 (Zimmer GmbH, 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K003523.
How does its category compare?
All KWA devicesKWA 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
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 2025
MAUDE reports naming product code KWA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 74 | 0 | 213 |
| 2008 | 9 | 57 | 13 | 762 |
| 2009 | 7 | 139 | 0 | 820 |
| 2010 | 6 | 167 | 84 | 3,348 |
| 2011 | 11 | 101 | 28 | 17,737 |
| 2012 | 4 | 76 | 21 | 24,601 |
| 2013 | 0 | — | 1 | 20,020 |
| 2014 | 0 | — | 0 | 16,494 |
| 2015 | 0 | — | 0 | 12,339 |
| 2016 | 0 | — | 1 | 7,872 |
| 2017 | 0 | — | 1 | 6,847 |
| 2018 | 0 | — | 1 | 6,388 |
| 2019 | 0 | — | 2 | 7,628 |
| 2020 | 0 | — | 1 | 4,538 |
| 2021 | 0 | — | 0 | 2,064 |
| 2022 | 0 | — | 0 | 1,617 |
| 2023 | 0 | — | 19 | 1,474 |
| 2024 | 0 | — | 0 | 1,168 |
| 2025 | 0 | — | 0 | 1,216 |
| 2026 | 0 | — | 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. prwrusio acerabu/i, 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 DcPuv Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062426 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062426: 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/K062426
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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