# K994425: Modification to Endoscopic Spinal Access System

- Pathway: 510(k) (Traditional)
- Applicant: Endius, Inc.
- Decided: Feb 16, 2000 after 48 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
No predicates in its family tree.
44 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sofamor Danek USA Microendoscopic Discectomy System: named in the summary without a submission number

## Most influential descendants
- K021748: Endius Atavi System (2002), 43 descendants of its own
- 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

## Indications for use
the Endius Endoscopic Access System is intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy and non-instrumented posterolateral fusion procedures. Warning: The Endius Endoscopic Access System is not intended to be used for other types of fusion procedures such as posterior lumbar interbody fusions (non-instrumented or instrumented) or posterolateral fusions which employ instrumentation (pedicle screws/cages)

Source page: https://510kreport.com/device/K994425
Methodology: https://510kreport.com/methodology