# K192646: SYMPHONY™ OCT System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Apr 2, 2020 after 191 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: 17 generations back to K040583 (2004). 146 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181949: SYMPHONY™ OCT System, Medos International SARL (2018) Summary page 4.
- K190895: MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System, Medos International SARL (2019) Summary page 4.
- K192014: SYPMHONY™ OCT System, Medos International SARL (2020). Cleared while this submission was under review Summary page 4.
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.
- K151885: SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System, Depuy Synthes, Inc. (2015) Summary page 4.
- K180851: VERTEX™ Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2018) Summary page 4.

## Most influential descendants
- K203319: SYMPHONY™ OCT System (2021), 1 descendant of its own
- K233366: SYMPHONY OCT System (2023), 0 descendants of its own

## Indications for use
The SYMPHONY OCT System 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 upper thoracic spine (T1-T3): • Traumatic spinal fractures and/or traumatic dislocations; • Instability or deformity; • Failed previous fusions (e.g. pseudarthrosis); • Tumors involving the cervical/thoracic spine; • 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 SYMPHONY 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. The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods. The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine. The SYMPHONY OCT System may be connected to the EXPEDIUM Spine System and VIPER System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.

Source page: https://510kreport.com/device/K192646
Methodology: https://510kreport.com/methodology