# K040493: Outologous Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Sciences, Inc.
- Decided: Sep 3, 2004 after 190 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Outologous Spinal Fixation System is a pedicle screw fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion. In addition, the Outologous Spinal Fixation System is intended to provide immobilization and stabilization of the 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 spines: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture of the vertebral body, dislocation, scoliosis, kyphosis, spinal tumor, and failed fusions (pseudoarthrosis).

Source page: https://510kreport.com/device/K040493
Methodology: https://510kreport.com/methodology