510(k) · Cleared
ClearedPINNACLETM Constrained Acetabular Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Apr 4, 2024 as substantially equivalent to K043058 (Depuy, Inc., 2005) and 2 other predicates after a 29-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Apr 4, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K883460 (1988). 9 ancestors in all, the oldest K851422 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK883460 Focus Total Hip SystemDepuy, Inc. · 1988
- 3 generations backK980513 Articul/Eze Femoral HeadsDePuy Orthopaedics, Inc. · 1998
- 2 generations backK060031 Depuy Modular M HeadsDePuy Orthopaedics, Inc. · 2006
- 1 generation backK071117 Modification to Pinnacle Constrained Acetabular LinersDePuy Orthopaedics, Inc. · 2007 · Recalled
- This deviceK240639 PINNACLETM Constrained Acetabular LinersDepuy Ireland UC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K883460 | Focus Total Hip System | Depuy, Inc. | 1988 | — |
| −3 | K980513 | Articul/Eze Femoral Heads | DePuy Orthopaedics, Inc. | 1998 | — |
| −2 | K060031 | Depuy Modular M Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| −1 | K071117 | Modification to Pinnacle Constrained Acetabular Liners | DePuy Orthopaedics, Inc. | 2007 | 1 |
| 0 (this device) | K240639 | PINNACLETM Constrained Acetabular Liners | Depuy Ireland UC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 KWZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWZ device
- #1 K241461 Mpact Constrained Linerscore 15.5 · 10 generations · no Class I recall
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 |
|---|---|---|---|
| * | K043058 | Pinnacle Constrained Acetabular LinersSummary page 6…/Polymer Page 1 of 4 Legally marketed device(s) to which K043058/K052079/K071117 - PINNACLETM Constrained Acetabular Liners equivalence is claimed Reason for 510(k) submission DePuy Ire… | 2005 |
| * | K052079 | Pinnacle Constrained Acetabular LinersSummary page 6…Page 1 of 4 Legally marketed device(s) to which K043058/K052079/K071117 - PINNACLETM Constrained Acetabular Liners equivalence is claimed Reason for 510(k) submission DePuy Ireland UC… | 2005 |
| * | K071117 | Modification to Pinnacle Constrained Acetabular LinersSummary page 6…Page 1 of 4 Legally marketed device(s) to which K043058/K052079/K071117 - PINNACLETM Constrained Acetabular Liners equivalence is claimed Reason for 510(k) submission DePuy Ireland UC has comp… | 2007 |
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 36 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 2 other devices also cite its predicate K043058.
How does its category compare?
All KWZ devicesKWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · KWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWZ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWZ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWZ
193in 2025
MAUDE reports naming product code KWZ, 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 | 7 | 104 | 0 | 41 |
| 2008 | 1 | — | 0 | 44 |
| 2009 | 1 | — | 0 | 81 |
| 2010 | 1 | — | 8 | 98 |
| 2011 | 1 | — | 0 | 127 |
| 2012 | 1 | — | 1 | 168 |
| 2013 | 0 | — | 0 | 274 |
| 2014 | 0 | — | 0 | 278 |
| 2015 | 0 | — | 0 | 636 |
| 2016 | 1 | — | 0 | 1,180 |
| 2017 | 2 | — | 0 | 477 |
| 2018 | 0 | — | 0 | 283 |
| 2019 | 0 | — | 0 | 532 |
| 2020 | 0 | — | 0 | 288 |
| 2021 | 0 | — | 0 | 216 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 1 | 164 |
| 2024 | 1 | — | 0 | 145 |
| 2025 | 1 | — | 0 | 193 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The PINNACLETM Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history or prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options of constrained acetabular components have been considered.
The PINNACLETM Constrained Acetabular Liner is indicated for use with the PINNACLETM Acetabular Cup in cementless application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240639 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240639: PINNACLETM Constrained Acetabular Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240639
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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