# K132900: Marauder Cervical-Thoracic Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Implant Systems, LLC
- Decided: Oct 25, 2013 after 39 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.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050979: S4 Spinal System, Aesculap, Inc. (2005) Summary page 1.
- K081107: Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors, K2m, Inc. (2008) Summary page 1.
- K070573: Synapse System, Synthes Spine Co.Lp (2007) Summary page 1.

## Indications for use
The MarauderTM Cervical-Thoracic Spinal Fixation System is intended to promote fusion of the cervical and thoracic spine (C] -T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine. The use of screws is limited to placement in TI-T3 for treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K132900
Methodology: https://510kreport.com/methodology