# K132332: Mountaineer Oct Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medos International SARL
- Decided: Aug 22, 2013 after 27 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: 11 generations back to K853033 (1985). 17 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041203: Summit Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 1.
- 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.
- K110353: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2011) Summary page 1.

## Most influential descendants
- K150254: Streamline OCT Occipito-Cervico-Thoracic System (2015), 2 descendants of its own
- K161498: Streamline OCT Occipito-Cervico-Thoracic System (2016), 1 descendant of its own
- K181350: ASTRA-OCT Spine System (2018), 0 descendants of its own
- K172139: Streamline OCT Occipito-Cervico-Thoracic System (2017), 0 descendants of its own

## Indications for use
The MOUNTAINEER OCT Spinal System is intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), and is indicated for the following: DOD (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 (Tl-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. The SONGER® wire/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, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM systems using the dual wedding band and axial connectors, and via dual diameter rods.

Source page: https://510kreport.com/device/K132332
Methodology: https://510kreport.com/methodology