# K062447: Traverse Oct Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Oct 15, 2007 after 419 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: 3 generations back to K003780 (2001). 4 ancestors in all.
107 later devices descend from it; 1 cites it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043020: Glaxy 3.2 Spinal System, Medtronic Sofamor Danek (2005) Summary page 2.

## Most influential descendants
- 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
- K133746: Polaris Spinal System (2014), 67 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and the thoracic spine, (C 1-T3), the TRAVERSETM 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. Hooks and Rods The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C 1-T3) spine. Screws/Connectors The use of screws is limited to placement in TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine. Titanium ATLASTM Cable used with the TRAVERSETM Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

Source page: https://510kreport.com/device/K062447
Methodology: https://510kreport.com/methodology