# K780375: Pavlik Harness

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 15, 1978 after 7 days
- Product code: IOZ (Splint, Abduction, Congenital Hip Dislocation)
- Device class: 1
- Regulation: 21 CFR 890.3665
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

Source page: https://510kreport.com/device/K780375
Methodology: https://510kreport.com/methodology