# K190600: ORION Spinal System

- Pathway: 510(k) (Abbreviated)
- Applicant: Orion Biotech, Inc.
- Decided: Aug 18, 2020 after 529 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 2 generations back to K981676 (1999). 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)
- K161231: Facilis™ Spinal System, Baui Biotech Co., Ltd. (2017) Summary page 4.

## Indications for use
The “ORION” Spinal System is a non-cervical, pedicle screw system intended to provide posterior, non-cervical 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 neurological impairment; fracture; dislocation; scoliosis; kyphosis; spinal stenosis; tumor; pseudarthrosis and/or failed previous fusion. In addition, the “ORION” Spinal System is also indicated for the treatment of the skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, having fusion by autogenous bone graft, with implant fixed or attached to the lumbar and sacral spine (L3 to Sacrum), and for whom the implants is intended to be removed after solid fusion is achieved.

Source page: https://510kreport.com/device/K190600
Methodology: https://510kreport.com/methodology