# K081906: Protex CT Cervicothoracic Spinal System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Nov 14, 2008 after 134 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: 9 generations back to K853033 (1985). 20 ancestors in all.
104 later devices descend from it; 5 cite it directly.
1 of 125 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050391: Protex CT Cervicothoracic Spinal System, Globus Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K090565: Ellipse Occipito-Cerico-Thoracic Spinal System (2009), 101 descendants of its own
- K110963: Ellipse Occipito-Cervico-Thoracic Spinal System (2011), 98 descendants of its own
- K123783: Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants (2013), 97 descendants of its own
- K150552: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS (2015), 96 descendants of its own
- K161591: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (2016), 78 descendants of its own

## Indications for use
The PROTEX® CT Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors. The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine. The 3.2mm rod implants are for use in the cervical and upper thoracic spine and are not intended for occipital fixation. The PROTEX® CT Occipito-Cervico-Thoracic Spinal System 3.7mm rods can also be linked to rod systems ranging in diameter from 3.7mm to 6.5mm, including the PROTEX® or REVERE System, using corresponding parallel connectors.

Source page: https://510kreport.com/device/K081906
Methodology: https://510kreport.com/methodology