# K021382: Synthes (Usa) Automated Tack Driver

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: May 16, 2002 after 14 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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 K000560 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000560: Synthes (Usa) Resorbable Tack System, Synthes (Usa) (2001) Summary page 1.

## Indications for use
Synthes Resorbable Tack System is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skeleton. Synthes Resorbable Tack System is not intended for use in the mandible or other full load-bearing situations, for areas with active infection or for patient conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.

Source page: https://510kreport.com/device/K021382
Methodology: https://510kreport.com/methodology