# K141284: Caspian Spinal System

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Jul 23, 2014 after 68 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: 15 generations back to K003155 (2001). 106 ancestors in all.
No later device cites it as a predicate yet.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081107: Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors, K2m, Inc. (2008) Summary page 1.
- K101084: Caspian Spinal System, K2m, Inc. (2010)
- K033961: Altius Oct System, Interpore Cross Intl. (2004) Summary page 1.
- K043229: Modification to Altius Oct System, Interpore Cross Intl. (2004) Summary page 1.
- K122378: Nextgen Altius Oct System, Biomet Spine (Aka Ebi, LLC) (2012) Summary page 1.

## 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-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and 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 the 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 rod connectors or transitional rods.

Source page: https://510kreport.com/device/K141284
Methodology: https://510kreport.com/methodology