# K063550: System 12 Constrained Acetabular Liners

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 8, 2007 after 104 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
A Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in 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.

Source page: https://510kreport.com/device/K063550
Methodology: https://510kreport.com/methodology