# K080258: Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Endius, Inc.
- Decided: Mar 10, 2008 after 39 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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 K003780 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070282: Endius Minit Posterior Cervical and Upper Thoracic Fixation System, Endius, Inc. (2007) Summary page 2.

## Indications for use
When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the Endius Minit Posterior Cervical and Upper Thoracic 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 l-T3) spine. Screws/Connectors The use of screws is limited to placement in the Ti-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine. Axial and Offset Rod Connectors The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE and TiTLE2 Polyaxial Spinal Systems offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.

Source page: https://510kreport.com/device/K080258
Methodology: https://510kreport.com/methodology