# K990572: Sonotome

- Pathway: 510(k) (Traditional)
- Applicant: Sonokinetics, Inc.
- Decided: May 21, 1999 after 87 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K853143 (1985). 7 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930629: Acryl-X II System, Sonokinetics, Inc. (1994) Summary page 1.
- K853143: Cooper Laser Sonics Cusa Model 200, Cooper Lasersonics, Inc. (1985) Summary page 1.
- K864983: Cusa System 200 Macro-Dissector, Cooper Lasersonics, Inc. (1987) Summary page 1.
- K884412: Cusa System 200C,T & M Ultrasonic Surgical Aspira., Valleylab, Inc. (1988) Summary page 1.
- K884413: Cusa System 200H Ultrasonic Surgical Aspirator, Valleylab, Inc. (1988) Summary page 1.
- K894600: Cusa System 200C,T,M,H Ultrasonic Aspirator, Valleylab, Inc. (1990) Summary page 1.
- K910696: Cusa (R) System 200C/200T/200M/200H Ultra Aspirator, Valleylab, Inc. (1991) Summary page 1.

## Most influential descendants
- K152699: Apollo System (2016), 4 descendants of its own
- K171332: Artemis Neuro Evacuation Device (2017), 2 descendants of its own
- K201308: Axonpen, Axonmonitor, Axonbox, Tablet (2020), 1 descendant of its own
- K230125: Neuroblade System (2023), 0 descendants of its own
- K181731: MR Compatible Aspiration Kit (2018), 0 descendants of its own

## Indications for use
The SONOTOME System is intended for the following indications: Breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic Surgery.

Source page: https://510kreport.com/device/K990572
Methodology: https://510kreport.com/methodology