# K122163: Certex Spinal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Oct 31, 2012 after 103 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K853033 (1985). 39 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050979: S4 Spinal System, Aesculap, Inc. (2005) Summary page 2.
- K062934: Sierra, Seaspine, Inc. (2006) Summary page 2.
- K090224: Fortex Pedicle Screw System, X-Spine Systems, Inc. (2009) Summary page 2.

## Most influential descendants
- K133094: Certex Oct Spinal Implant System (2013), 1 descendant of its own
- K160428: Certex Spinal Fixation System (2016), 0 descendants of its own

## Indications for use
The intended use of the Certex Spinal Implant System is to promote fusion of the subaxial cervical spine and cervico-thoracic junction (C3 -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, " Failed previous fusion, * Revision of previous cervical spine surgery, * Spinal tumors. The use of screws is limited to placement in TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K122163
Methodology: https://510kreport.com/methodology