# K101563: Smarto

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Dec 17, 2010 after 196 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: 1 generation back to K933101 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933101: The Osteomed B Power System and Accessories, Osteomed Corp. (1994) Summary page 1.

## Most influential descendants
- K163308: Smarto (2016), 0 descendants of its own

## 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/K101563
Methodology: https://510kreport.com/methodology