# K060683: Endius Minit Posterior Cervical and Upper Thoracic Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Endius, Inc.
- Decided: Apr 18, 2006 after 34 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). 6 ancestors in all.
32 later devices descend from it; 2 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)
- K052180: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2005) Summary page 2.
- K991089: Synthes Cervifix System, Synthes Spine (1999) Summary page 2.
- K001864: Synthes Cervifix System, Synthes Spine (2000)
- (no number) Synthes Spine Starlock Systems: named in the summary without a submission number

## Most influential descendants
- K070282: Endius Minit Posterior Cervical and Upper Thoracic Fixation System (2007), 31 descendants of its own
- 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

## Indications for use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1 -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-'1'3) spine. Screws/Connectors The use of screws is limited to placement in the TI -T3 in treating thoracic conditions only. Screws arc not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K060683
Methodology: https://510kreport.com/methodology