# K240639: PINNACLETM Constrained Acetabular Liners

- Pathway: 510(k) (Special)
- Applicant: Depuy Ireland UC
- Decided: Apr 4, 2024 after 29 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
Longest line of descent: 4 generations back to K883460 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043058: Pinnacle Constrained Acetabular Liners, Depuy, Inc. (2005) Summary page 6.
- K052079: Pinnacle Constrained Acetabular Liners, DePuy Orthopaedics, Inc. (2005) Summary page 6.
- K071117: Modification to Pinnacle Constrained Acetabular Liners, DePuy Orthopaedics, Inc. (2007) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K240639
Methodology: https://510kreport.com/methodology