# K181350: ASTRA-OCT Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Spinecraft, LLC
- Decided: Jul 6, 2018 after 45 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K853033 (1985). 262 ancestors in all.
No later device cites it as a predicate yet.
0 of 263 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080828: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2008) Summary page 4.
- K110353: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2011) Summary page 4.
- K151885: SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System, Depuy Synthes, Inc. (2015) Summary page 4.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 4.
- K103100: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2010) Summary page 4.
- K132332: Mountaineer Oct Spinal System, Medos International SARL (2013) Summary page 4.
- K090714: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek (2009) Summary page 4.
- K091365: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Soafamor Danek (2009) Summary page 4.
- K093434: Vertex Reconstruction System and Vertex Select Reconstruction System, Medtronic Sofamor Danek (2009) Summary page 4.
- K110522: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 4.
- K123656: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4.
- K143471: VERTEX Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K090549: Synthes Synapse Transconnector, Synthes Spine (2009) Summary page 4.
- K133698: Synapse System, Synthes USA Products, LLC (2014) Summary page 4.
- K141897: Synapse System, Synthes OC Fusion System, Synthes USA Products, LLC (2014) Summary page 4.
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.
- K013222: Summit Occipito-Cervico- Thoracic (Oct) Spinal System, Depuyacromed (2001) Summary page 4.
- K022190: Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System, Depuyacromed (2002) Summary page 4.
- K030103: Summit Oct Spinal System Minipolyaxial Screws, Depuyacromed (2003) Summary page 4.
- K041203: Summit Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 4.
- K150552: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS, Globus Medical, Inc. (2015) Summary page 4.
- K132122: Kestrel Posterior Cervical Spine System, Omni Surgical, LLC Dba Spine360 (2014) Summary page 4.

## Indications for use
The ASTRA-OCT Spine 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. The ASTRA-OCT Spine System 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, the ASTRA-OCT Spine System rods may be connected to other occipital cervical thoracic or thoracolumbar stabilization rod systems ranging in diameter from 3.5mm to 6.35mm, including the ASTRA or APEX Spine Systems, using corresponding connectors.

Source page: https://510kreport.com/device/K181350
Methodology: https://510kreport.com/methodology