510(k) · Cleared
ClearedPinnacle Constrained Acetabular Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Mar 14, 2005 after a 129-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Mar 14, 2005
- Review
- 129 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK043058 Pinnacle Constrained Acetabular LinersDepuy, Inc. · 2005
- Descendant · cites it directly · 6 of its ownK071117 Modification to Pinnacle Constrained Acetabular LinersDePuy Orthopaedics, Inc. · 2007 · Recalled
- Descendant · cites it directly · 4 of its ownK153131 Logical C-Series Acetabular Shell, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK241690 Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK252824 Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball…Signature Orthopaedics Pty, Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK243162 World LinerSignature Orthopaedics Pty, Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K071117Modification to Pinnacle Constrained Acetabular LinersDePuy Orthopaedics, Inc. · 2007 · cites it directly6descendants
- K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd. · 2016 · cites it directly4descendants
- K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024 · 2 generations on2descendants
- K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd. · 2026 · 2 generations on0descendants
- K243162World LinerSignature Orthopaedics Pty, Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043058 | Pinnacle Constrained Acetabular Liners | Depuy, Inc. | 2005 | — |
| +1 | K071117 | Modification to Pinnacle Constrained Acetabular Liners | DePuy Orthopaedics, Inc. | 2007 | 1 |
| +1 | K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical… | Signature Orthopaedics Pty, Ltd. | 2016 | — |
| +2 | K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024 | — |
| +2 | K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | 2026 | — |
| +3 | K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 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 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
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Biomet RingLoc II Constrained Liners Named without a submission number | |
| * | — | Biomet Freedom Constrained Liners Named without a submission number | |
| * | — | DePuy SROM Poly-Dial Acetabular Cup System Constrained Liners Named without a submission number | |
| * | — | DePuy Duraloc Acetabular Cup System Constrained Liners Named without a submission number |
What descends from it? (7)
3 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?
- Of its descendants, K071117 (DePuy Orthopaedics, Inc., 2007) has gone furthest, with 6 descendants of its own.
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.
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 Pinnacle® 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 of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
The Pinnacle® Constrained Acetabular Liner is indicated for use with the Pinnacle® Acetabular Cup in cementless application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043058 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043058: Pinnacle 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/K043058
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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