# K013301: Uni-T Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Vision, Inc.
- Decided: Feb 13, 2002 after 133 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SCS Claris Spinal System, Orthotec, Inc.: named in the summary without a submission number
- (no number) CD Horizon, Sofamor Danek: named in the summary without a submission number

## Most influential descendants
- K133575: Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle Screw Fixation System (2014), 3 descendants of its own
- K160124: LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System (2016), 2 descendants of its own
- K200267: LOSPA® IS™ Spinal Fixation System (2020), 1 descendant of its own
- K240180: Orthopeasia Spinal Fixation System (2024), 0 descendants of its own
- K052406: Uni-Thread Spinal System (2005), 0 descendants of its own

## Indications for use
The UNI-T 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-T 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/K013301
Methodology: https://510kreport.com/methodology