# K043058: Pinnacle Constrained Acetabular Liners

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Mar 14, 2005 after 129 days
- Product code: KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Biomet RingLoc II Constrained Liners: named in the summary without a submission number
- (no number) Biomet Freedom Constrained Liners: named in the summary without a submission number
- (no number) DePuy SROM Poly-Dial Acetabular Cup System Constrained Liners: named in the summary without a submission number
- (no number) DePuy Duraloc Acetabular Cup System Constrained Liners: named in the summary without a submission number

## Most influential descendants
- K071117: Modification to Pinnacle Constrained Acetabular Liners (2007), 6 descendants of its own
- K153131: Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner (2016), 4 descendants of its own
- K241690: Logical Liner; World Liner; World Knee Patella (2024), 2 descendants of its own
- K252824: Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (2026), 0 descendants of its own
- K243162: World Liner (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K043058
Methodology: https://510kreport.com/methodology