# K021510: Uni-T Uni-Thread Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Vision, Inc.
- Decided: Aug 1, 2002 after 84 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) UNI-T Uni-Thread Spinal System: named in the summary without a submission number

## Most influential descendants
- K052406: Uni-Thread Spinal System (2005), 0 descendants of its own
- K042640: Uni-Thread Spinal System (2004), 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-SI 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 hsion (pseudoarthrosis)

Source page: https://510kreport.com/device/K021510
Methodology: https://510kreport.com/methodology