# K171444: YUKON OCT Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Aug 8, 2017 after 84 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K853033 (1985). 265 ancestors in all.
13 later devices descend from it; 4 cite it directly.
1 of 279 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081107: Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors, K2m, Inc. (2008) Summary page 4.
- K101084: Caspian Spinal System, K2m, Inc. (2010) Summary page 4.
- K153370: Caspian OCT/MESA Mini/DENALI Mini Spinal System, K2m, Incorporated (2016) Summary page 4.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 4.
- K110353: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2011) Summary page 4.
- K133556: Virage Oct Spinal Fixation System, Zimmer Spine, Inc. (2014) Summary page 4.
- K151224: Lineum OCT Spine System, Biomet Spine (2015) Summary page 4.
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.
- K982322: Synthes Spine Occipital-Cervical Plate/Rod and Hook System, Synthes (Usa) (1998) Summary page 4.
- K984377: Synthes Spine Cervifix System, Synthes (Usa) (1999) Summary page 4.
- K052402: Vertex Reconstruction System, Medtronic Sofamor Danek (2005) Summary page 4.
- K083071: Vertex Reconstruction System, Medtronic Sofamor Danek (2008) Summary page 4.

## Most influential descendants
- K182182: YUKON OCT Spinal System (2018), 5 descendants of its own
- K181603: EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System (2018), 5 descendants of its own
- K222684: XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (2023), 4 descendants of its own
- 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

## Recalls of this device
- Jun 13, 2022 · Class II · Z-1307-2022: Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammator
- Dec 14, 2020 · Class II · Z-0931-2021: The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
- Jul 24, 2018 · Class II · Z-0110-2020: Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective review of 

## 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 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 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 absence 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 Spinal System components via the rod to rod connectors or transition rods.

Source page: https://510kreport.com/device/K171444
Methodology: https://510kreport.com/methodology