# K242674: Freedom Posterior Cervical Screws

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: May 13, 2025 after 249 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: 17 generations back to K853033 (1985). 204 ancestors in all.
No later device cites it as a predicate yet.
0 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182508: Saxxony™ Posterior Cervical Thoracic System, Nexxt Spine, LLC (2018) Summary page 5.

## Indications for use
The Signature Orthopaedics Freedom Cervical Screw and Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (C1 to C7) as an adjunct to fusion in the treatment of the following acute and chronic instabilities and deformities of the cervical spine: * traumatic spinal fractures and/or traumatic dislocations * instability or deformity; failed previous fusions (e.g. pseudarthrosis) » degenerative disease, including neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability, and * short term stabilization 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 expectancy is of insufficient duration to permit achievement of fusion.

Source page: https://510kreport.com/device/K242674
Methodology: https://510kreport.com/methodology