# K061345: Modification to Endius Atavi System

- Pathway: 510(k) (Special)
- Applicant: Endius, Inc.
- Decided: Jun 6, 2006 after 22 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K991794 (1999). 7 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 25 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) Summary page 2.
- K021748: Endius Atavi System, Endius, Inc. (2002) Summary page 2.
- K022199: Endius Atavi System, Endius, Inc. (2002) Summary page 2.
- K053267: Endius Atavi System, Endius, Inc. (2006) Summary page 2.

## Most influential descendants
- K081051: Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope (2008), 16 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
- K090278: Enspire Debrider System (2009), 7 descendants of its own
- K110992: Enspire Debrider System (2011), 6 descendants of its own
- K120553: ESPIN (2012), 2 descendants of its own

## Recalls of this device
- Feb 8, 2013 · Class II · Z-1045-2013: Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached inner pouch h

## Indications for use
The Endius Atavi System is indicated for use for posterior or anterior access and visualization in the surgical area of cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius Atavi system would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

Source page: https://510kreport.com/device/K061345
Methodology: https://510kreport.com/methodology