# K083073: Theken Atoll Cervico-Thoracic System

- Pathway: 510(k) (Special)
- Applicant: Theken Spine, LLC
- Decided: Mar 13, 2009 after 149 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: 9 generations back to K853033 (1985). 18 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070638: Theken Atoll Cervico-Thoracic System, Theken Spine, LLC (2007) Summary page 1.
- K080790: Modification to Theken Atoll Cervico-Thoracic System, Theken Spine, LLC (2008) Summary page 1.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 2.

## Most influential descendants
- K122292: Reliance Posterior Cervical- Thoracic System (2012), 4 descendants of its own
- K142867: Reliance Posterior Cervical-Thoracic System (2015), 3 descendants of its own
- K213394: Vy Spine™ VySpan™ PCT System (2021), 2 descendants of its own
- K223852: VySpan™ PCT System (2023), 1 descendant of its own
- K120998: Solstice Cross Connector (2012), 1 descendant of its own

## Indications for use
The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (Cl - T3). The intended indications are as follows: · Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) · Spondylolisthesis • Spinal Stenosis · Fracture/Dislocation · Tumors · Pseudoarthrosis · Revision of previous cervical and upper thoracic spine surgery The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C I-T3) spine. The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

Source page: https://510kreport.com/device/K083073
Methodology: https://510kreport.com/methodology