# K944836: Osteonics Restoration Monolithic II  Hip Stem Series

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Apr 10, 1995 after 192 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Dec 2, 2002 · Not classified · Z-0467-03: Product mix-up. 16mm stem in a 18mm package.

Source page: https://510kreport.com/device/K944836
Methodology: https://510kreport.com/methodology