# K153743: Piezosurgery Plus

- Pathway: 510(k) (Traditional)
- Applicant: Mectron S.P.A.
- Decided: May 25, 2016 after 149 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). 30 ancestors in all.
2 later devices descend from it; 2 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)
- K132848: Piezosurgery Flex, Mectron S.P.A. (2013) Summary page 5.
- K070313: Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator System, Misonix, Inc. (2007) Summary page 5.

## Most influential descendants
- 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
- 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® Plus is an ultrasonic surgical system consisting of handpieces and associated tips for 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, and - Orthopedic surgery. The device may also be used with endoscopic visual assistance to perform the above listed procedures.

Source page: https://510kreport.com/device/K153743
Methodology: https://510kreport.com/methodology