# K923616: Omniflex-C Uhmwpe Mid-Shaft Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Oct 30, 1992 after 101 days
- Product code: JDK (Prosthesis, Hip, Cement Restrictor)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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
- K021765: Cement Restrictor, Small and Large (2002), 1 descendant of its own
- K210062: Mectaplug PE II (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K923616
Methodology: https://510kreport.com/methodology