# K052241: Disc-FX System

- Pathway: 510(k) (Traditional)
- Applicant: Ellman International, Inc.
- Decided: Feb 24, 2006 after 191 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
No predicates in its family tree.
38 later devices descend from it; 4 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K081051: Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope (2008), 16 descendants of its own
- K062038: X-Sten Mild Tool Kit, Model MTK-0001 (2006), 14 descendants of its own
- K093062: Vertos Medical Mild Device Kit (2010), 13 descendants of its own
- K180876: DTRAX Spinal System (2018), 7 descendants of its own
- K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor (2011), 7 descendants of its own

## Indications for use
The Disc-FX TM System is intended for use in ablation and coagulation of intervertebral disc material during discectomy procedures in the lumbar spine.

Source page: https://510kreport.com/device/K052241
Methodology: https://510kreport.com/methodology