# K983485: Synthes 1.3 MM Self-Drilling Screw

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 21, 1998 after 77 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: 1 generation back to K953806 (1996). 1 ancestor in all.
171 later devices descend from it; 8 cite it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953806: Synthes (Usa) Midfacial System, Synthes (Usa) (1996) 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
Synthes 1.3 mm Self-Drilling Screws are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Source page: https://510kreport.com/device/K983485
Methodology: https://510kreport.com/methodology