# K062879: Traverse Oct Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Dec 22, 2006 after 87 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: 5 generations back to K853033 (1985). 14 ancestors in all.
151 later devices descend from it; 1 cites it directly.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052402: Vertex Reconstruction System, Medtronic Sofamor Danek (2005) Summary page 1.
- K052734: Modification to: Vertex Reconstruction System, Medtronic Sofamor Danek (2005) Summary page 1.

## Most influential descendants
- K070742: Modification to Vertex Reconstruction System (2007), 150 descendants of its own
- K110522: Vertex Reconstruction System, Vertex Select Reconstruction System (2011), 106 descendants of its own
- 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

## Indications for use
When intended to promote fusion of the occipitocervical spine, the cervical spine, and the thoracic spine, (Occiput-T3), the TRAVERSE OCT Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Occipitocervical Plate/Rod/Occipital Screws/Hooks The occipitocervical plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. The use of the occipitocervical plates and rods requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs. Hooks The hooks are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Multi-Axial Screws/Connectors The use of multi-axial screws is limited to placement of T1-T3. The screws are not intended to be placed in the cervical spine. Titanium ATLAS® Cable used with the TRAVERSE OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

Source page: https://510kreport.com/device/K062879
Methodology: https://510kreport.com/methodology