# K150552: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jun 4, 2015 after 92 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K853033 (1985). 201 ancestors in all.
96 later devices descend from it; 5 cite it directly.
1 of 298 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143471: VERTEX Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K090565: Ellipse Occipito-Cerico-Thoracic Spinal System, Globus Medical, Inc. (2009) Summary page 4.
- K110963: Ellipse Occipito-Cervico-Thoracic Spinal System, Globus Medical, Inc. (2011) Summary page 4.
- K123783: Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants, Globus Medical, Inc. (2013) Summary page 4.
- K050391: Protex CT Cervicothoracic Spinal System, Globus Medical, Inc. (2005) Summary page 4.
- K081906: Protex CT Cervicothoracic Spinal System, Globus Medical, Inc. (2008) Summary page 4.
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.

## Most influential descendants
- K161591: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (2016), 78 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own
- K153370: Caspian OCT/MESA Mini/DENALI Mini Spinal System (2016), 17 descendants of its own

## Recalls of this device
- Aug 25, 2017 · Class II · Z-0626-2018: The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.

## Indications for use
ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal System implants are intended 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-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. These implants are 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. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

Source page: https://510kreport.com/device/K150552
Methodology: https://510kreport.com/methodology