# K090565: Ellipse Occipito-Cerico-Thoracic Spinal System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Jun 30, 2009 after 120 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: 10 generations back to K853033 (1985). 21 ancestors in all.
101 later devices descend from it; 5 cite it directly.
1 of 123 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.
- K081906: Protex CT Cervicothoracic Spinal System, Globus Medical, Inc. (2008) Summary page 1.
- K032394: Stryker Spine Oasys System, Howmedica Osteonics Corp. (2004) Summary page 1.

## Most influential descendants
- 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
- K171651: Excelsius GPS (2017), 69 descendants of its own

## Indications for use
The ELLIPSE TM 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 ELLIPSE TM Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.5mm to 6.5mrm, including the PROTEX® or REVERE® or BEACONTm System, using corresponding parallel connectors.

Source page: https://510kreport.com/device/K090565
Methodology: https://510kreport.com/methodology