# K133094: Certex Oct Spinal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Dec 11, 2013 after 72 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K853033 (1985). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122163: Certex Spinal Implant System, X-Spine Systems, Inc. (2012) Summary page 2.
- K062012: S4 Cervical Occipital Plate Spinal System, Aesculap, Inc. (2007) Summary page 2.

## Most influential descendants
- K160428: Certex Spinal Fixation System (2016), 0 descendants of its own

## Indications for use
The intended use of the Certex OCT Spinal Implant System is to promote fusion of the occipito-cervico-thoracic regions of the spine (Occiput - T3 inclusive). The indications for use are as follows: - Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), * Spondylolisthesis, * Trauma (i.e., fracture or dislocation), * Spinal Stenosis, * Atlanto-axial fracture with instability, * Failed previous fusion, * Occipito-cervical dislocation, * Revision of previous cervical spine surgery, * Spinal tumors. The occipital bone screws are limited to occipital fixation only. The hooks and rods are intended to provide stabilization and promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic spine (C1-T3). The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for purposes of anchoring an OCT construct, and are not intended for treatment of thoracic conditions. Screws are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K133094
Methodology: https://510kreport.com/methodology