# K151885: SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Synthes, Inc.
- Decided: Sep 3, 2015 after 56 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: 3 generations back to K953076 (1997). 4 ancestors in all.
41 later devices descend from it; 11 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.

## Most influential descendants
- K150474: NuVasive VuePoint II OCT System (2015), 26 descendants of its own
- K153370: Caspian OCT/MESA Mini/DENALI Mini Spinal System (2016), 17 descendants of its own
- K171444: YUKON OCT Spinal System (2017), 13 descendants of its own
- K181949: SYMPHONY™ OCT System (2018), 10 descendants of its own
- K190895: MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System (2019), 9 descendants of its own

## Indications for use
The SUMMIT® SI OCT Spinal Fixation System and MOUNTAINEER® OCT Spinal System are 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. pseudarthrosis); * tumors involving the cervical/thoracic 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 SUMMIT and MOUNTAINEER Systems are 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. The SONGER® Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable attachment to the posterior cervical spine. The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA®, MONARCH®, MOSS® MIAMI, VIPER® and EXPEDIUM® Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods.

Source page: https://510kreport.com/device/K151885
Methodology: https://510kreport.com/methodology