510(k) · Cleared
ClearedDepuy Pinnacle Metal-on-Metal Acetabular Cup Liner
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 10, 2002 as substantially equivalent to K002883 (DePuy Orthopaedics, Inc., 2000) after a 27-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Dec 10, 2002
- Review
- 27 days
- Class
- Class III
- Product code
- KWA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002883 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK002883 Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2000
- This deviceK023786 Depuy Pinnacle Metal-on-Metal Acetabular Cup LinerDePuy Orthopaedics, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK083642 Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002883 | Pinnacle Metal-on-Metal Acetabular Cup Liners | DePuy Orthopaedics, Inc. | 2000 | — |
| 0 (this device) | K023786 | Depuy Pinnacle Metal-on-Metal Acetabular Cup Liner | DePuy Orthopaedics, Inc. | 2002 | — |
| +1 | K083642 | Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners | DePuy Orthopaedics, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002883 | Pinnacle Metal-on-Metal Acetabular Cup LinersSummary page 1…al-On-Metal Acetabular Cup Liners in 44mm OD x 28mm ID and 46mm OD x 28mm ID sizes are identical to the previously cleared Pinnacle Metal-On-Metal Acetabular Cup Liners, K002883. The additional outer diameter sizes of 44mm and 46mm are manufactured from the same material and have the same intended use as t… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083642 | Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners | 2009 | 0 |
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?
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 Metalan-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hi replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint fro rheumatoid arthritis, oste&hritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and non-union c femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia…
Read the full statement (106 words)
The Pinnacle Metalan-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hi replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint fro rheumatoid arthritis, oste&hritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and non-union c femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio ucetubul slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for othc reconstructionprocedures.
The Pinnacle 28mm Metal-On-Metal Acetabular Cup Liners are intended for use with the DePuy Pinnac Acetabular Shells and 28 nun diameter Co-Cr-Mo femoral heads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023786: Depuy Pinnacle Metal-on-Metal Acetabular Cup Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023786
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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