510(k) · Cleared
Recalled · Class II · 2012Modification to Pinnacle Constrained Acetabular Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on May 18, 2007 as substantially equivalent to K052079 (DePuy Orthopaedics, Inc., 2005) and 2 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1988. 6 later devices descend from it. It has been recalled once.
- Decided
- May 18, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K883460 (1988). 8 ancestors in all, the oldest K851422 (1985). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK883460 Focus Total Hip SystemDepuy, Inc. · 1988
- 2 generations backK980513 Articul/Eze Femoral HeadsDePuy Orthopaedics, Inc. · 1998
- 1 generation backK060031 Depuy Modular M HeadsDePuy Orthopaedics, Inc. · 2006
- This deviceK071117 Modification to Pinnacle Constrained Acetabular LinersDePuy Orthopaedics, Inc. · 2007
- 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
- Descendant · cites it directly · 0 of its ownK240639 PINNACLETM Constrained Acetabular LinersDepuy Ireland UC · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883460 | Focus Total Hip System | Depuy, Inc. | 1988 | — |
| −2 | K980513 | Articul/Eze Femoral Heads | DePuy Orthopaedics, Inc. | 1998 | — |
| −1 | K060031 | Depuy Modular M Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| 0 (this device) | K071117 | Modification to Pinnacle Constrained Acetabular Liners | DePuy Orthopaedics, Inc. | 2007 | — |
| +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 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K052079 | Pinnacle Constrained Acetabular LinersSummary page 1…sis DEVICE PRODUCT CODE: 87 KWZ SUBSTANTIALLY EQUIVALENT DePuy Pinnacle® Constrained Acetabular Liner, DEVICE: K052079 DePuy Pinnacle® Constrained Acetabular Liner, K043058… | 2005 |
| * | K043058 | Pinnacle Constrained Acetabular LinersSummary page 1…ner, DEVICE: K052079 DePuy Pinnacle® Constrained Acetabular Liner, K043058 DePuy Modular M Femoral Head, K060031… | 2005 |
| * | K060031 | Depuy Modular M HeadsSummary page 1…DePuy Pinnacle® Constrained Acetabular Liner, K043058 DePuy Modular M Femoral Head, K060031 11… | 2006 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 22, 2012 | Class II | Z-2414-2012 | Labeling Change Control | Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series Designation. We have received one complaint regarding this issue. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K153131 (Signature Orthopaedics Pty, Ltd., 2016) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K052079.
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. 2007, 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 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/K071117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071117: Modification to Pinnacle Constrained Acetabular Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071117
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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