# K210887: Altus Spine Sochi OCT Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Altus Partners, LLC
- Decided: Aug 20, 2021 after 148 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K853033 (1985). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083863: Theken Atoll Oct Spinal System, Theken Spine, LLC (2009) Summary page 4.

## Indications for use
The Altus Spine Sochi OCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: Traumatic spine fractures and/or traumatic dislocations; Instability or deformity; Failed previous fusions (e.g. pseudarthrosis); Tumors involving the cervical spine; Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Altus Spine Sochi OCT System is also intended to restore the integrity of the spinal column even in the absent of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Altus Spine Sochi OCT System may be used with the Theken Coral Spinal System with the use of transition rods and rod connectors.

Source page: https://510kreport.com/device/K210887
Methodology: https://510kreport.com/methodology