# K071117: Modification to Pinnacle Constrained Acetabular Liners

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: May 18, 2007 after 28 days
- Product code: KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K883460 (1988). 8 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052079: Pinnacle Constrained Acetabular Liners, DePuy Orthopaedics, Inc. (2005) Summary page 1.
- K043058: Pinnacle Constrained Acetabular Liners, Depuy, Inc. (2005) Summary page 1.
- K060031: Depuy Modular M Heads, DePuy Orthopaedics, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K240639: PINNACLETM Constrained Acetabular Liners (2024), 0 descendants of its own

## Recalls of this device
- Aug 22, 2012 · Class II · Z-2414-2012: 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 regard

## 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/K071117
Methodology: https://510kreport.com/methodology