# K122662: Vertiflex Direct Decompression System

- Pathway: 510(k) (Traditional)
- Applicant: Vertiflex, Inc.
- Decided: Nov 13, 2012 after 74 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: 6 generations back to K922881 (1992). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093062: Vertos Medical Mild Device Kit, X-Sten Corp. (2010) Summary page 1.

## Indications for use
The Vertilex® Direct Decompression System is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.

Source page: https://510kreport.com/device/K122662
Methodology: https://510kreport.com/methodology