# K193129: Yukon OCT Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Feb 7, 2020 after 87 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- 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: 19 generations back to K853033 (1985). 267 ancestors in all.
No later device cites it as a predicate yet.
1 of 268 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182182: YUKON OCT Spinal System, K2m (2018) Summary page 4.
- K171444: YUKON OCT Spinal System, K2m, Inc. (2017) Summary page 4.
- K080143: Modification to Stryker Spine Oasys System, Stryker Spine (2008) Summary page 4.
- K032394: Stryker Spine Oasys System, Howmedica Osteonics Corp. (2004) Summary page 4.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 4.

## Recalls of this device
- Nov 3, 2020 · Class II · Z-0520-2021: Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical interv

## 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 (C1 to C7) and the thoracic spine (T1-T3); traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusion (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 degenerative 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 absences of fusion for a limited time period in patients with advanced stage tumors 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/K193129
Methodology: https://510kreport.com/methodology