# K070638: Theken Atoll Cervico-Thoracic System

- Pathway: 510(k) (Traditional)
- Applicant: Theken Spine, LLC
- Decided: May 30, 2007 after 84 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: 4 generations back to K853033 (1985). 10 ancestors in all.
59 later devices descend from it; 6 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990965: Synthes Cervifix System, Synthes (Usa) (1999) Summary page 1.
- K003780: Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K002733: Summit Occipito-Cervico-Thoracic (Oct) Spinal System, Depuyacromed (2000) Summary page 1.

## Most influential descendants
- K092295: Pioneer Posterior Cervico-Thoracic System (2010), 24 descendants of its own
- K083863: Theken Atoll Oct Spinal System (2009), 21 descendants of its own
- K112757: Pioneer Posterior Cervico Thoracic System (2012), 18 descendants of its own
- K121725: Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System (2012), 17 descendants of its own
- K141222: Nautilus Spinal System and Solstice Oct System (2015), 13 descendants of its own

## Indications for use
The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1-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; and 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 (C1-T3) spine.

Source page: https://510kreport.com/device/K070638
Methodology: https://510kreport.com/methodology