# K103232: Caspian Spinal System

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Jan 13, 2011 after 72 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.
46 later devices descend from it; 2 cite it directly.
0 of 76 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.
- K092640: Caspian Spinal System, K2m, Inc. (2009) Summary page 1.
- K093534: Modification to Caspian Spinal System, K2m, Inc. (2009) Summary page 1.
- K101084: Caspian Spinal System, K2m, Inc. (2010) Summary page 1.
- K033961: Altius Oct System, Interpore Cross Intl. (2004) Summary page 1.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 1.

## Most influential descendants
- K120656: Everest Spinal System (2012), 43 descendants of its own
- K132757: Everest Spinal System (2013), 41 descendants of its own
- K132361: Everest Spinal System (2013), 34 descendants of its own
- K133944: Range, Spinal System, Everest Spinal System (2014), 33 descendants of its own
- K140529: Everest Spinal System (2014), 31 descendants of its own

## Indications for use
The Caspian 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 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 Spinal 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/K103232
Methodology: https://510kreport.com/methodology