# K233332: Statera-C™ Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K&J Consulting Corp.
- Decided: Nov 27, 2023 after 59 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: 16 generations back to K853033 (1985). 202 ancestors in all.
No later device cites it as a predicate yet.
0 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150552: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS, Globus Medical, Inc. (2015) Summary page 5.

## Indications for use
The Statera-C™ 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 cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and 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. It 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. In order to achieve additional levels of fixation, the Statera-C™ Spinal System may be connected to the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System using corresponding connectors and/or transition rods.

Source page: https://510kreport.com/device/K233332
Methodology: https://510kreport.com/methodology