# K163308: Smarto

- Pathway: 510(k) (Special)
- Applicant: Jeil Medical Corporation
- Decided: Dec 27, 2016 after 34 days
- Product code: KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933101 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101563: Smarto, Jeil Medical Corporation (2010) Summary page 4.

## Indications for use
The SMARTO is intended for use in driving screws, and drilling in conjunction with craniofacial (does not include oromaxillofacial applications), craniotomnies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and single use only.

Source page: https://510kreport.com/device/K163308
Methodology: https://510kreport.com/methodology