# K160428: Certex Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: May 5, 2016 after 79 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). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151938: S4 Cervical Spinal and Occiput Systems, Aesculap Implant Systems, LLC (2015) Summary page 5.
- K133094: Certex Oct Spinal Implant System, X-Spine Systems, Inc. (2013) Summary page 5.
- K122163: Certex Spinal Implant System, X-Spine Systems, Inc. (2012) Summary page 5.

## Indications for use
The intended use of the Certex Spinal Fixation System is 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 (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. The X-spine Certex Spinal Fixation 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 X-spine Certex Spinal Fixation System can be linked to X-spine Fortex® Pedicle Screw System and X-spine Xpress™ Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.

Source page: https://510kreport.com/device/K160428
Methodology: https://510kreport.com/methodology