# K983144: Flexposure Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Endius, Inc.
- Decided: Feb 24, 1999 after 169 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: 1 generation back to K950130 (1995). 3 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955471: Incl Endoscope, Sofamor Danek USA,Inc. (1995) Summary page 1.
- K950501: Danek Rigid Arthroscope, Sofamor Danek USA,Inc. (1995) Summary page 1.
- K950130: Micro-Endo (TM) Instruments, Sofamor Danek USA,Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K190201: CORUS Spinal System (2019), 6 descendants of its own
- K212636: CORUS Spinal System-X (2021), 5 descendants of its own

## Indications for use
The Flexposure Retractor is a manual surgical instrument intended to provide endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures.

Source page: https://510kreport.com/device/K983144
Methodology: https://510kreport.com/methodology