# K081107: Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Oct 10, 2008 after 175 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
No predicates in its family tree.
64 later devices descend from it; 11 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Starlock/Cervifix: named in the summary without a submission number
- (no number) Interpore Mini VLS/Altius: named in the summary without a submission number
- (no number) DePuy Mountaineer: named in the summary without a submission number
- (no number) Spinal Concepts Octafix: named in the summary without a submission number

## Most influential descendants
- K101084: Caspian Spinal System (2010), 62 descendants of its own
- 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

## Indications for use
The Caspian Spinal System 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 Hooks and Rods-The rod and hook components are also intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Rods and Pedicle Screws-The rods and screws are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

Source page: https://510kreport.com/device/K081107
Methodology: https://510kreport.com/methodology