# K133556: Virage Oct Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Jun 2, 2014 after 195 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K003155 (2001). 85 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070282: Endius Minit Posterior Cervical and Upper Thoracic Fixation System, Endius, Inc. (2007) Summary page 3.
- K071435: Nuvasive Oct System, Nuvasive, Inc. (2007) Summary page 3.
- K091689: Synapse System 4.0MM, OC Fusion System 4.0MM, Synthes (Usa) (2009) Summary page 3.
- K991089: Synthes Cervifix System, Synthes Spine (1999) Summary page 3.
- K994187: Synthes Cervifix System, Synthes (Usa) (1999) Summary page 3.
- K003780: Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2001) Summary page 3.
- K123656: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 3.

## Most influential descendants
- K171444: YUKON OCT Spinal System (2017), 13 descendants of its own
- K150918: PASS OCT Spinal System (2015), 13 descendants of its own
- K182182: YUKON OCT Spinal System (2018), 5 descendants of its own
- K181603: EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System (2018), 5 descendants of its own
- K173522: Solanas® Posterior Stabilization System (2017), 5 descendants of its own

## Recalls of this device
- Feb 3, 2016 · Class II · Z-1019-2016: Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual.
- Nov 17, 2015 · Class II · Z-0625-2016: Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the inser

## Indications for use
When intended to promote fusion of the occipitocervical spine, cervical spine and the thoracic spine, (Occiput -T3), the Virage OCT Spinal Fixation System is indicated for the following: Degenerative disc disease (DDD) (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Occipitocervical Plate/Rod/Occipital Screws/Hooks Occipitocervical plate, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat occipitocervical and cervical conditions, the occipital screws are limited to occipital fixation only. The occipital screws are not intended for the cervical spine. Hooks and Rods Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Thoracic Screws The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. The thoracic screws are not intended to be placed in the cervical spine. Rod Connectors The Virage OCT Spinal Fixation System can also be linked to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine using rod connectors and transition rods. The titanium SONGER Spinal Cable System to be used with the Virage OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

Source page: https://510kreport.com/device/K133556
Methodology: https://510kreport.com/methodology