# K132848: Piezosurgery Flex

- Pathway: 510(k) (Traditional)
- Applicant: Mectron S.P.A.
- Decided: Nov 29, 2013 after 79 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: 7 generations back to K862807 (1986). 25 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 32 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 1.
- K100410: Piezoelectric System, Satelec (2010) Summary page 1.

## Most influential descendants
- 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
- K192033: Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip (2020), 0 descendants of its own

## Indications for use
The Piezosurgery FLEX is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.

Source page: https://510kreport.com/device/K132848
Methodology: https://510kreport.com/methodology