# K083863: Theken Atoll Oct Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Theken Spine, LLC
- Decided: Mar 27, 2009 after 88 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: 10 generations back to K853033 (1985). 19 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 41 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.
- K080828: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2008) Summary page 1.
- K053418: Synthes OC Fusion System, Synthes Spine Co.Lp (2006) Summary page 1.

## Most influential descendants
- K141222: Nautilus Spinal System and Solstice Oct System (2015), 13 descendants of its own
- K151196: Nautilus Spinal System (2015), 12 descendants of its own
- K191575: ARx Spinal System (2019), 10 descendants of its own
- K200070: ARx Spinal System (2020), 9 descendants of its own
- K203163: ARx Illiac Spinal Screw System (2020), 5 descendants of its own

## Indications for use
The Atoll OCT Spinal System is indicated to promote fusion of the occipito-cervico-thoracic regions of the spine (Occiput - 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 · Atlanto/axial fracture with instability · Occipitocervical dislocation Revision of previous cervical and upper thoracic spine surgery The occipital bone screws are limited to occipital fixation only. The use of the polyaxial and standard screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. 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 OCT Spinal 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/K083863
Methodology: https://510kreport.com/methodology