# K221307: Edge Upper Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Simplicity, LLC
- Decided: Jul 10, 2023 after 431 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: 14 generations back to K003155 (2001). 93 ancestors in all.
No later device cites it as a predicate yet.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161032: neon3™  universal OCT spinal stabilization, Ulrich GmbH & Co. KG (2016) Summary page 4.

## Indications for use
The Edge upper cervical 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 (Cl to C7) and the thoracic spine (TI to T3): * Traumatic spinal fractures and/or traumatic dislocations; * instability or deformity; * failed previous fusions (e.g., pseudarthrosis); * tumors involving the cervical/thoracic 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 Edge UCS 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 Edge UCS is intended for use only with the Innosys AnaxTM OCT Spinal System.

Source page: https://510kreport.com/device/K221307
Methodology: https://510kreport.com/methodology