# K072961: Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)

- Pathway: 510(k) (Traditional)
- Applicant: Sra Developments, Ltd.
- Decided: Dec 19, 2007 after 61 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: 4 generations back to K900003 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051053: Oscar, Model OE3000DB, Orthosonics, Ltd. (2005) Summary page 2.

## Indications for use
The LOTUS Ultrasonic System for Cemented Implant extraction System (USCIX) is indicated for the softening of bone cement to facilitate the removal of implants, including pedicle screws and other spinal implants, during revision surgery.

Source page: https://510kreport.com/device/K072961
Methodology: https://510kreport.com/methodology