# K122861: XTOOL

- Pathway: 510(k) (Traditional)
- Applicant: Ouroboros Medical
- Decided: Dec 7, 2012 after 80 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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 K002764 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041233: Arthrojet XT, Hydrocision, Inc. (2004) Summary page 2.
- K972768: Blackstone Medical, Inc. Laparoscopic Disc Removal System, Blackstone Medical, Inc. (1997) Summary page 2.

## Most influential descendants
- K213978: TELIGEN System (2022), 0 descendants of its own

## Indications for use
The XTooTM Device is indicated for spinal discectomy procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries.

Source page: https://510kreport.com/device/K122861
Methodology: https://510kreport.com/methodology