# K962774: Osteomed Quickfix

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Oct 10, 1997 after 451 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K151195: OsteoMed IMF Screw (2015), 0 descendants of its own

## Indications for use
Smooth or threaded metallic bone fixation fastener; Intraoral ligature and wire lock. Bone screws and associated instruments (Drill bits, screwdrivers,etc.) in conjunction with ligature wire and associated instruments (wire twisters, cutters, etc.) Temporary ligature and wire lock fixation for temporary constriction and stabilization of fractured bone segments in the oral cavity in conjunction with primary fixation devices.

Source page: https://510kreport.com/device/K962774
Methodology: https://510kreport.com/methodology