# K021748: Endius Atavi System

- Pathway: 510(k) (Special)
- Applicant: Endius, Inc.
- Decided: Jun 26, 2002 after 29 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 K991794 (1999). 3 ancestors in all.
43 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991794: Endoscopic Spinal Access System, Endius, Inc. (1999) Summary page 2.
- K994425: Modification to Endoscopic Spinal Access System, Endius, Inc. (2000) Summary page 2.
- K002437: Endius Endoscopic Access System, Endius, Inc. (2000)

## Most influential descendants
- K053267: Endius Atavi System (2006), 42 descendants of its own
- K061246: Endoscopic Spine System (2006), 25 descendants of its own
- K061345: Modification to Endius Atavi System (2006), 17 descendants of its own
- 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

## Indications for use
The Endius Atavi System is indicated for use in instrumented posterolateral fusion procedures where the TriFix Spinal Instrumentation System is utilized. The Endius Atavi System is also intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy, non-instrumented posterolateral fusion procedures.

Source page: https://510kreport.com/device/K021748
Methodology: https://510kreport.com/methodology