# K974785: Auto-Drive Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Mar 18, 1998 after 86 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: 3 generations back to K761228 (1976). 12 ancestors in all.
141 later devices descend from it; 6 cite it directly.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM), KLS-Martin L.P. (1994) Summary page 1.
- K970912: Leibinger Self-Drilling Screw, Howmedica Leibinger, Inc. (1997) Summary page 1.

## Most influential descendants
- K013954: Lorenz Self Drilling Screws (2002), 117 descendants of its own
- K032228: Lorenz 2.4 Self Drilling Screws (2003), 101 descendants of its own
- K033740: Lorenz Sternal Closure System (2003), 100 descendants of its own
- K063506: Lorenz Sternal Closure System (2006), 87 descendants of its own
- K110574: Biomet Microfixation Sternalock Blu Sternal Closure System (2011), 84 descendants of its own

## Indications for use
Fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand

Source page: https://510kreport.com/device/K974785
Methodology: https://510kreport.com/methodology