# K992583: Mass (Micro-Access Spine System)

- Pathway: 510(k) (Traditional)
- Applicant: Omni-Tract Surgical, Div. Minn. Scientific, Inc.
- Decided: Oct 29, 1999 after 88 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 K842762 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842762: Omni-Tract Surgical Retractor Sys, Minnesota Scientific, Inc. (1984) Summary page 1.
- K853947: Omni-Tract Chest Wall & Luna Retractor, Minnesota Scientific, Inc. (1985) Summary page 1.
- K872919: Omni-Tract Corral Retractor, Minnesota Scientific, Inc. (1987) Summary page 1.

## Indications for use
The intended use is for spinal surgery that is consistent with the working dimensions of the retractor/access port.

Source page: https://510kreport.com/device/K992583
Methodology: https://510kreport.com/methodology