# K100410: Piezoelectric System

- Pathway: 510(k) (Traditional)
- Applicant: Satelec
- Decided: Apr 28, 2010 after 71 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: 6 generations back to K862807 (1986). 24 ancestors in all.
8 later devices descend from it; 3 cite it directly.
1 of 33 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083284: Piezosurgery Medical, Piezosurgery S.R.L. (2009) Summary page 2.
- K043310: Synthes (Usa) Electric Pen Drive System, Synthes (Usa) (2005) Summary page 2.
- K091252: Implant Center 2, Satelec (2009) Summary page 2.

## Most influential descendants
- K132848: Piezosurgery Flex (2013), 6 descendants of its own
- K172464: XD880A Ultrasonic Osteotomy Surgical System (2018), 2 descendants of its own
- K153743: Piezosurgery Plus (2016), 2 descendants of its own
- K243280: Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) (2025), 0 descendants of its own
- K201274: Ultrasonic Osteotomy Surgical System (2021), 0 descendants of its own

## Indications for use
The Piezoelectric System, distributed by Synthes, is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for osteotom~y, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.

Source page: https://510kreport.com/device/K100410
Methodology: https://510kreport.com/methodology