# K861114: Mallory/Head - PF Acetabular Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 17, 1986 after 23 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042841: M2A/C2A Acetabular System (2004), 1 descendant of its own
- K113271: Metal-on-Metal Hip Systems-Additional Contraindications (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K861114
Methodology: https://510kreport.com/methodology