# K212636: CORUS Spinal System-X

- Pathway: 510(k) (Traditional)
- Applicant: Providence Medical Technology, Inc.
- Decided: Oct 15, 2021 after 57 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: 8 generations back to K922881 (1992). 42 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190201: CORUS Spinal System, Providence Medical Technology, Inc. (2019) Summary page 4.
- K093062: Vertos Medical Mild Device Kit, X-Sten Corp. (2010) Summary page 4.

## Most influential descendants
- K240625: CORUS Navigation Access System (2024), 4 descendants of its own
- K260329: Ion-C Navigation Instruments (2026), 1 descendant of its own
- K262121: Ion-L Navigated Instruments (2026), 0 descendants of its own
- K251060: CORUS™ Navigation System-GX (2025), 0 descendants of its own
- K243659: FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (2025), 0 descendants of its own

## Indications for use
For Cervical Fusion: CORUSTM Spinal System-X is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease. For Lumbar Fusion: CORUSTM Spinal System-X is a set of instruments indicated to be used to perform posterior lumbar fusion in patients with lumbar degenerative disc disease.

Source page: https://510kreport.com/device/K212636
Methodology: https://510kreport.com/methodology