# K052406: Uni-Thread Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Vision, Inc.
- Decided: Nov 7, 2005 after 67 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: 1 generation back to K013301 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013301: Uni-T Spinal System, Spine Vision, Inc. (2002) Summary page 1.
- K021510: Uni-T Uni-Thread Spinal System, Spine Vision, Inc. (2002) Summary page 1.

## Indications for use
The Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who: • have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; • receive fusions using autogenous bone graft only; * have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and * have the device removed after the development of a solid fusion. In addition, the Uni-Thread Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: * Degenerative spondylolisthesis with objective evidence of neurologic impairment * fracture * dislocation * scoliosis * kyphosis * spinal tumor * failed previous fusion (pseudoarthrosis)

Source page: https://510kreport.com/device/K052406
Methodology: https://510kreport.com/methodology