# K133288: Caspian Oct Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Jul 1, 2014 after 249 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K853033 (1985). 29 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101084: Caspian Spinal System, K2m, Inc. (2010) Summary page 1.
- K052402: Vertex Reconstruction System, Medtronic Sofamor Danek (2005) Summary page 1.

## Most influential descendants
- K153370: Caspian OCT/MESA Mini/DENALI Mini Spinal System (2016), 17 descendants of its own
- 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

## Indications for use
The CASPIAN OCT/MESA Mini/DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervical-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following: - DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); - Spondylolisthesis; - Spinal stenosis; - Fracture/dislocation; - Revision of previous cervical spine surgery; - Tumors; - Atlantoaxial fracture with instability; - Occipitocervical dislocation The occipital bone screws are limited to occipital fixation only. The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine. The CASPIAN OCT/MESA Mini/Denali Mini System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.

Source page: https://510kreport.com/device/K133288
Methodology: https://510kreport.com/methodology