# K182508: Saxxony™ Posterior Cervical Thoracic System

- Pathway: 510(k) (Traditional)
- Applicant: Nexxt Spine, LLC
- Decided: Nov 13, 2018 after 62 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). 203 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150552: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS, Globus Medical, Inc. (2015) Summary page 4.
- K070638: Theken Atoll Cervico-Thoracic System, Theken Spine, LLC (2007) Summary page 4.
- K994187: Synthes Cervifix System, Synthes (Usa) (1999) Summary page 4.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 4.
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.

## Most influential descendants
- K242516: EUROPA™ Posterior Cervical Fusion System (2024), 2 descendants of its own
- K252327: CMORE® CT System; CMORE® CT System Navigated Instruments (2025), 1 descendant of its own
- K254045: CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (2026), 0 descendants of its own
- K242674: Freedom Posterior Cervical Screws (2025), 0 descendants of its own

## Indications for use
The Saxxony™ Posterior Cervical Thoracic System is intended to immobilize and stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments as an adjunct to fusion for the treatment of the following acute and chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); 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 Saxxony™ Posterior Cervical Thoracic 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 Saxxony™ Posterior Cervical Thoracic System rods may be connected to cervicothoracic or thoracolumbar stabilization systems ranging in diameter from 3.5mm to 6.5mm, using corresponding rod to rod connectors and/or transition rods.

Source page: https://510kreport.com/device/K182508
Methodology: https://510kreport.com/methodology