# K241700: Tenex 2nd Generation System

- Pathway: 510(k) (Traditional)
- Applicant: Trice Medical, Inc.
- Decided: Nov 18, 2024 after 158 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: 5 generations back to K884413 (1988). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181367: Tenex Health TX System with the TXP MicroTip, Tenex Health, Inc. (2018) Summary page 5.

## Indications for use
The Tenex® 2nd Generation System is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of both soft and hard (e.g.: bone) tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery, and Plastic and Reconstructive Surgery. The Tenex® 2nd Generation System is also indicated for use in the debridement of wounds, such as, but not limited to diabetic ulcers, in application, in which, in the physician’s judgement would require the use of an ultrasonic aspirator with sharp debridement.

Source page: https://510kreport.com/device/K241700
Methodology: https://510kreport.com/methodology