# K101084: Caspian Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Oct 4, 2010 after 168 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: 9 generations back to K853033 (1985). 24 ancestors in all.
62 later devices descend from it; 6 cite it directly.
0 of 87 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)
- K002733: Summit Occipito-Cervico-Thoracic (Oct) Spinal System, Depuyacromed (2000) Summary page 1.
- K050391: Protex CT Cervicothoracic Spinal System, Globus Medical, Inc. (2005) Summary page 1.
- K070573: Synapse System, Synthes Spine Co.Lp (2007) Summary page 1.
- K030197: Blackstone Posterior Cervical System, Blackstone Medical, Inc. (2003) Summary page 1.
- K984377: Synthes Spine Cervifix System, Synthes (Usa) (1999) Summary page 1.

## Most influential descendants
- K103232: Caspian Spinal System (2011), 46 descendants of its own
- K113654: Caspian (2012), 44 descendants of its own
- 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

## 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 * Occipitocervi6al 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/K101084
Methodology: https://510kreport.com/methodology