# K081459: Cusa Selector NXT Ultrasonic Tissue Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Integra Radionics, Inc.
- Decided: Aug 13, 2008 after 82 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K884413 (1988). 15 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071669: Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip, Integra Radionics, Inc. (2007) Summary page 1.
- K042277: Selector Quantum Ultrasonic Aspirator System, Integra Neurosciences, Ltd. (2004) Summary page 1.
- K021989: Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3, Integra Neurosciences (2002) Summary page 1.

## Most influential descendants
- K161882: CUSA Clarity Ultrasonic Surgical Aspirator System (2016), 11 descendants of its own
- K182809: CUSA Clarity Ultrasonic Surgical Aspirator System (2018), 10 descendants of its own
- K200774: CUSA Clarity Ultrasonic Surgical Aspirator System (2020), 5 descendants of its own
- K221235: neXus Ultrasonic Surgical Aspirator System (2022), 2 descendants of its own
- K102258: Cusa NXT Extended Length Tip (2011), 2 descendants of its own

## Recalls of this device
- Sep 29, 2014 · Class II · Z-0491-2015: Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.
- May 2, 2011 · Not classified · Z-2585-2011: The insulated covering of a wire cable that powers the vacuum pump in the CUSA NXT Service Module can become abraded over time resulting in the exposure of bare wire. If this bare wire were to come in
- Jul 29, 2010 · Not classified · Z-2638-2010: A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the CUSA NXT Service module to run at maximum speed, and continue to run until the entire system is turned 
- Jul 29, 2010 · Not classified · Z-2637-2010: A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the CUSA NXT Service module to run at maximum speed, and continue to run until the entire system is turned 

## Indications for use
The CUSA SelectorTM NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

Source page: https://510kreport.com/device/K081459
Methodology: https://510kreport.com/methodology