# K023260: 1.2MM Osteomed Auto-Drive Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Oct 18, 2002 after 18 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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). 15 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974785: Auto-Drive Bone Screw, Osteomed Corp. (1998) Summary page 1.
- K983485: Synthes 1.3 MM Self-Drilling Screw, Synthes (Usa) (1998) Summary page 1.
- K970912: Leibinger Self-Drilling Screw, Howmedica Leibinger, Inc. (1997) Summary page 1.

## Most influential descendants
- K031659: Universal Neuro System (2003), 12 descendants of its own
- K112557: Stryker Universal Neuro 3 System (2012), 9 descendants of its own
- K073342: Salvin Dental Specialties, Inc., Fixation Screw (2008), 5 descendants of its own
- K120352: Stryker Quikflap Sterile Procedure Pack (2012), 4 descendants of its own
- K063589: Gso Bone Fixation Fasteners (2007), 4 descendants of its own

## Indications for use
Indicated for fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand. 1.2mm Auto-Drive Screws are intended for single patient use only.

Source page: https://510kreport.com/device/K023260
Methodology: https://510kreport.com/methodology