# K103100: Mountaineer Oct Spinal System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Nov 17, 2010 after 28 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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.
184 later devices descend from it; 3 cite it directly.
1 of 201 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080828: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2008) Summary page 1.
- K041203: Summit Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 1.

## Most influential descendants
- K113593: Nextgen Altius Oct System (2012), 102 descendants of its own
- K110963: Ellipse Occipito-Cervico-Thoracic Spinal System (2011), 98 descendants of its own
- K123783: Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants (2013), 97 descendants of its own
- K150552: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS (2015), 96 descendants of its own
- K161591: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (2016), 78 descendants of its own

## Indications for use
The indications for use for the modified devices described in this submission are the same as those for the MOUNTAINEER OCT Spinal System. The indications are as follows: 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: * ddd (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/K103100
Methodology: https://510kreport.com/methodology