# K070282: Endius Minit Posterior Cervical and Upper Thoracic Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Endius, Inc.
- Decided: Sep 6, 2007 after 220 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: 4 generations back to K003780 (2001). 7 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060683: Endius Minit Posterior Cervical and Upper Thoracic Fixation System, Endius, Inc. (2006) Summary page 2.

## Most influential descendants
- K133556: Virage Oct Spinal Fixation System (2014), 27 descendants of its own
- K171444: YUKON OCT Spinal System (2017), 13 descendants of its own
- K150918: PASS OCT Spinal System (2015), 13 descendants of its own
- K182182: YUKON OCT Spinal System (2018), 5 descendants of its own
- K181603: EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System (2018), 5 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and the thoracic spine, (CI-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 (C1-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 Coniectors The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE and TiTLE 2 System 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/K070282
Methodology: https://510kreport.com/methodology