# K200936: Invictus™ CT Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: May 22, 2020 after 44 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: 27 generations back to K841189 (1984). 890 ancestors in all.
3 later devices descend from it; 2 cite it directly.
3 of 894 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.
- K192938: Invictus™ Spinal Fixation System, Alphatec Spine, Inc. (2019) 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.
- K200130: M.U.S.T. MINI Posterior Cervical Screws System, Medacta International S.A. (2020) Summary page 4.
- K161591: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments, Globus Medical, Inc. (2016) Summary page 4.
- K182182: YUKON OCT Spinal System, K2m (2018) Summary page 4.
- K181440: Proficient® Posterior Cervical Spine System, Spine Wave, Inc. (2018) Summary page 4.
- K153631: Zimmer Virage OCT Spinal Fixation System, Zimmer Spine, Inc. (2016) Summary page 5.
- K180851: VERTEX™ Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2018) Summary page 5.

## Most influential descendants
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants of its own
- K203125: Invictus™ OCT Spinal Fixation System (2020), 0 descendants of its own

## Indications for use
The Invictus™ CT Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of 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.,pseudoarthrosis); tumors involving the cervical 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 Invictus CT 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 CT Spinal Fixation System may be connected to the components in the Arsenal® Spinal Fixation System or the Invictus™ Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.

Source page: https://510kreport.com/device/K200936
Methodology: https://510kreport.com/methodology