# K050391: Protex CT Cervicothoracic Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jul 21, 2005 after 155 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: 8 generations back to K853033 (1985). 19 ancestors in all.
148 later devices descend from it; 7 cite it directly.
1 of 168 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003780: Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K042524: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2004) Summary page 1.
- K002733: Summit Occipito-Cervico-Thoracic (Oct) Spinal System, Depuyacromed (2000) Summary page 1.
- K041203: Summit Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 1.
- K032394: Stryker Spine Oasys System, Howmedica Osteonics Corp. (2004) Summary page 1.
- K023675: Synthes Cervifix/ Axon, Synthes (Usa) (2002) Summary page 1.

## Most influential descendants
- K081906: Protex CT Cervicothoracic Spinal System (2008), 104 descendants of its own
- 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

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the PROTEXTM CT Spinal System is indicated for: 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 PROTEXTM CT System can also be linked to titanium rod systems ranging in diameter from 3.7mm to 6.5mm, including the PROTEXTM System, using parallel connectors.

Source page: https://510kreport.com/device/K050391
Methodology: https://510kreport.com/methodology