# K231654: NorthStar OCT System

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Aug 3, 2023 after 58 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: 12 generations back to K853033 (1985). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193615: NorthStar™ OCT Spinal System, SeaSpine Orthopedics Corporation (2020) Summary page 4.
- K080526: Sierra System, Seaspine, Inc. (2008) Summary page 4.

## Indications for use
The Northstar OCT 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, cervical spine (C1-C?), and upper thoracic spine (T1-T3): • Traumatic spinal fractures and/or traumatic dislocations, • Instability or deformity, • Failed previous fusion (e.g., pseudoarthrosis), • Tumors involving the cervical/thoracic spine, • Degenerative disease, including intractable radiculopathy and/or myelopathy and neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and • Degenerative disease of the facets with instability. The Northstar OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Northstar OCT System can also be linked to other FDA-cleared SeaSpine/Orthofix screw systems with the use of transitional rods and/or transitional rod connectors.

Source page: https://510kreport.com/device/K231654
Methodology: https://510kreport.com/methodology