# K081564: Creaspine Supstance Vertebral Body Replacement System Line Extension

- Pathway: 510(k) (Special)
- Applicant: Creaspine
- Decided: Jun 30, 2008 after 26 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K841189 (1984). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072537: Creaspine Supstance Vertebral Body Replacement System, Creaspine Sas (2007) Summary page 1.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 1.
- K003709: Surgical Dynamics Mesh Cage System, United States Surgical, A Division of Tyco Healthc (2001) Summary page 1.

## Indications for use
The Creaspine SupStance Vertebral Body Replacement System, Line Extension, (SupStance VBR System) is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoraco-lumbar spine (Ti- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use. The use of allograft and/or autograft with the SupStance VBR System is optional.

Source page: https://510kreport.com/device/K081564
Methodology: https://510kreport.com/methodology