# K172464: XD880A Ultrasonic Osteotomy Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Morley Research Consortium
- Decided: Apr 24, 2018 after 253 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: 8 generations back to K862807 (1986). 26 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132848: Piezosurgery Flex, Mectron S.P.A. (2013) Summary page 5.
- K100410: Piezoelectric System, Satelec (2010) Summary page 5.

## Most influential descendants
- K201274: Ultrasonic Osteotomy Surgical System (2021), 0 descendants of its own
- K190281: Ultrasonic Surgical System (2019), 0 descendants of its own

## Indications for use
XD880A 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/K172464
Methodology: https://510kreport.com/methodology