# K201274: Ultrasonic Osteotomy Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Smtp Technology Co., Ltd.
- Decided: Feb 19, 2021 after 283 days
- Product code: JDX (Instrument, Surgical, Sonic And Accessory/Attachment)
- Device class: 2
- Regulation: 21 CFR 888.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K862807 (1986). 27 ancestors in all.
No later device cites it as a predicate yet.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172464: XD880A Ultrasonic Osteotomy Surgical System, Morley Research Consortium (2018) Summary page 5.

## Indications for use
Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: - Otolaryngology - Oral/maxillofacial - Hand and foot - Neurosurgery - Spine - Plastic/reconstructive.

Source page: https://510kreport.com/device/K201274
Methodology: https://510kreport.com/methodology