# K142838: Synapse Occipital-Cervical-Thoracic (OCT) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA Products, LLC
- Decided: Jan 20, 2015 after 112 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953076 (1997). 3 ancestors in all.
192 later devices descend from it; 32 cite it directly.
1 of 196 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062254: Axis Fixation System, Medtronic Sofamor Danek, Inc. (2008) Summary page 4.

## Most influential descendants
- 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
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own
- K151885: SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System (2015), 41 descendants of its own

## Recalls of this device
- Sep 16, 2019 · Class II · Z-0223-2020: The subject product measures 4.0mm in diameter instead of 3.5mm.

## Indications for use
The Synapse OCT System, including Synapse, OC Fusion and Axon, is 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 to 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 Synapse OCT System is 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 Axon and Synapse Systems may be connected to the Synthes Universal Spinal System using parallel connectors and tapered rods. The Synapse OCT System can also be linked to the titanium DePuy EXPEDIUM Spine System using the 3.5mm/5.5mm and 4.0mm/5.5mm titanium tapered rods.

Source page: https://510kreport.com/device/K142838
Methodology: https://510kreport.com/methodology