# K190895: MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jul 18, 2019 after 104 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: 5 generations back to K953076 (1997). 9 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151885: SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System, Depuy Synthes, Inc. (2015) Summary page 7.
- K181949: SYMPHONY™ OCT System, Medos International SARL (2018) Summary page 7.
- K963350: Depuy Motech Peak Fixation System, Depuy, Inc. (1996) Summary page 7.
- K980368: Depuy Motech Peak 3MM Fixation Rod System, Depuy, Inc. (1998) Summary page 7.
- K982483: Depuy Motech Peak Fixation System, DePuy Orthopaedics, Inc. (1998) Summary page 7.

## Most influential descendants
- K200936: Invictus™ CT Spinal Fixation System (2020), 3 descendants of its own
- K192014: SYPMHONY™ OCT System (2020), 3 descendants of its own
- K192646: SYMPHONY™ OCT System (2020), 2 descendants of its own
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own
- K203319: SYMPHONY™ OCT System (2021), 1 descendant of its own

## Indications for use
The SUMMIT SI OCT Spinal Fixation System and MOUNTAINEER OCT Spinal System 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 to C7) and the 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 SUMMIT and MOUNTAINEER Systems 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. The SONGER Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable attachment to the posterior cervical spine. The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods. 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. The SUMMIT Plate System is intended for use in treating fractures of small bones such as the metacarpals, ulna, radius, humerus, and metatarsals, and in treating fractures of the lateral malleoulus, olecranon, and intra-articular distal tibia. The SUMMIT Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.

Source page: https://510kreport.com/device/K190895
Methodology: https://510kreport.com/methodology