# K921139: Healey Revision Component System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 1, 1992 after 113 days
- Product code: JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K990032: Modular Protusio Cup (1999), 1 descendant of its own
- K992359: MRS-Titan (2000), 0 descendants of its own

Source page: https://510kreport.com/device/K921139
Methodology: https://510kreport.com/methodology