# K151195: OsteoMed IMF Screw

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed
- Decided: Sep 21, 2015 after 140 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
Longest line of descent: 4 generations back to K761228 (1976). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962774: Osteomed Quickfix, Osteomed Corp. (1997) Summary page 4.
- K974785: Auto-Drive Bone Screw, Osteomed Corp. (1998) Summary page 4.

## Indications for use
The OsteoMed ICON IMF Screw System is intended and indicated for the temporary ligature and wire lock fixation for temporary constriction and stabilization of fracture bone segments in the oral cavity in conjunction with primary fixation devices.

Source page: https://510kreport.com/device/K151195
Methodology: https://510kreport.com/methodology