# K203125: Invictus™ OCT Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Dec 18, 2020 after 60 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: 28 generations back to K841189 (1984). 902 ancestors in all.
No later device cites it as a predicate yet.
3 of 903 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191185: Solanas® Posterior OCT Fixation System, Alphatec Spine (2019) Summary page 4.
- K200936: Invictus™ CT Spinal Fixation System, Alphatec Spine, Inc. (2020) Summary page 4.
- K153631: Zimmer Virage OCT Spinal Fixation System, Zimmer Spine, Inc. (2016) Summary page 4.
- K161032: neon3™  universal OCT spinal stabilization, Ulrich GmbH & Co. KG (2016) Summary page 4.
- K111076: Solanas Avalon Posterior Fixation System, Alphatec Spine, Inc. (2011) Summary page 4.
- K093319: Nuvasive Vuepoint Oct System, Nuvasive, Inc. (2010) Summary page 4.
- K200130: M.U.S.T. MINI Posterior Cervical Screws System, Medacta International S.A. (2020) Summary page 4.
- K161363: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2016) Summary page 5.
- K192938: Invictus™ Spinal Fixation System, Alphatec Spine, Inc. (2019) Summary page 5.

## Indications for use
The lnvictusTM OCT Spinal Fixation System is intended to provide inunobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7), and the thoracic spine from Tl-TI: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g.,pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confmned by radiographic studies, and degenerative disease of the facets with instability. The Invictus OCT Spinal Fixation 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 advance 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 Invictus OCT Spinal Fixation System may be connected to the components in the Arsenal® Spinal Fixation System or the InvictusTM Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.

Source page: https://510kreport.com/device/K203125
Methodology: https://510kreport.com/methodology