# K153370: Caspian OCT/MESA Mini/DENALI Mini Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Incorporated
- Decided: Feb 16, 2016 after 85 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: 16 generations back to K853033 (1985). 224 ancestors in all.
17 later devices descend from it; 4 cite it directly.
1 of 242 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150474: NuVasive VuePoint II OCT System, Nu Vasive, Incorporated (2015)
- K081107: Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors, K2m, Inc. (2008) Summary page 4.
- K133288: Caspian Oct Spinal System, K2m, Inc. (2014)
- K152338: VERTEX (r) Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K151755: OASYS (r) System, Stryker Corporation (2015) Summary page 4.
- K151885: SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System, Depuy Synthes, Inc. (2015) Summary page 4.
- K150552: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS, Globus Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K171444: YUKON OCT Spinal System (2017), 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
- K222684: XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (2023), 4 descendants of its own
- K200936: Invictus™ CT Spinal Fixation System (2020), 3 descendants of its own

## Indications for use
The Caspian OCT/MESA Mini/DENALI Mini Spinal 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 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 Caspian OCT/MESA Mini/DENALI Mini Spinal 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. In order to achieve additional levels of fixation, the Caspian OCT/MESA Mini/DENALI Mini Spinal System may be connected to Range/MESA/DENALI Spinal System and Everest Spinal System components via the rod to rod connectors or transition rods.

Source page: https://510kreport.com/device/K153370
Methodology: https://510kreport.com/methodology