# K182182: YUKON OCT Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m
- Decided: Nov 15, 2018 after 94 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K853033 (1985). 266 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 272 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171444: YUKON OCT Spinal System, K2m, Inc. (2017) Summary page 4.
- K153370: Caspian OCT/MESA Mini/DENALI Mini Spinal System, K2m, Incorporated (2016) Summary page 4.
- K110353: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2011)
- K133556: Virage Oct Spinal Fixation System, Zimmer Spine, Inc. (2014) Summary page 4.

## Most influential descendants
- K200936: Invictus™ CT Spinal Fixation System (2020), 3 descendants of its own
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants of its own
- K203125: Invictus™ OCT Spinal Fixation System (2020), 0 descendants of its own
- K193129: Yukon OCT Spinal System (2020), 0 descendants of its own

## Indications for use
The YUKON OCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction. the cervical spine (Cl to C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies. and degenerati ve disease of the facets with instability. The YUKON OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tu mors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation. the YUKON OCT Spinal System may be connected to EVEREST, MESA and DENALI Spinal System components via the rod to rod connectors or transition rods.

Source page: https://510kreport.com/device/K182182
Methodology: https://510kreport.com/methodology