# K142558: Caspian OCT/MESA Mini/DENALI Mini Spinal System

- Pathway: 510(k) (Special)
- Applicant: K2m
- Decided: Dec 22, 2014 after 102 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: 12 generations back to K853033 (1985). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 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 4.
- K092640: Caspian Spinal System, K2m, Inc. (2009) Summary page 4.
- K081107: Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors, K2m, Inc. (2008) Summary page 4.
- K121808: Casian, 3.5/4.5 Connectors, K2m, Inc. (2012) Summary page 4.
- K033961: Altius Oct System, Interpore Cross Intl. (2004) Summary page 4.

## 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 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 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 Spinal System can also be linked to the RANGE® Spinal System using rod connectors or transitional rods.

Source page: https://510kreport.com/device/K142558
Methodology: https://510kreport.com/methodology