# K243602: Arthrex Spine Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: May 16, 2025 after 176 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: 3 generations back to K953484 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130778: Discoscopes, Cervical Endoscopes, Rz Medizintechnik GmbH (2014) Summary page 5.

## Indications for use
The Arthrex Spine Endoscope is indicated for use to provide visualization during spinal endoscopic procedures and minimally invasive surgery.

Source page: https://510kreport.com/device/K243602
Methodology: https://510kreport.com/methodology