# K110353: Mountaineer Oct Spinal System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Apr 7, 2011 after 59 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K853033 (1985). 16 ancestors in all.
156 later devices descend from it; 13 cite it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 1.
- K080828: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2008) Summary page 1.

## Most influential descendants
- K113593: Nextgen Altius Oct System (2012), 102 descendants of its own
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System (2013), 75 descendants of its own
- K131615: Polaris Spinal System (2013), 70 descendants of its own
- K133746: Polaris Spinal System (2014), 67 descendants of its own
- K113654: Caspian (2012), 44 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal System is intended for: * ODD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * spondylolisthesis * spinal stenosis * fracture/dislocation * atlanto/axial fracture with instability * occipitocervical dislocation * revision of previous cervical spine surgery * tumors The occipital bone screws are limited to occipital fixation only. The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine. The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®, TiMX®, MONARCH®, EXPEDIUM®, VIPER® and MOSS® MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.

Source page: https://510kreport.com/device/K110353
Methodology: https://510kreport.com/methodology