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510(k) Data Aggregation
K Number
K072537Device Name
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM
Manufacturer
Date Cleared
2007-12-18
(99 days)
Product Code
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
CREASPINE SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Creaspine SupStance Vertebral Body Replacement System (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 thoracolumbar spine (T1- 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.
Device Description
The Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System) is a vertebral body replacement system, intended for use as an aid in spinal fusion. The SupStance VBR System consists of the SupStance VBR implant and the associated instrumentation required for implantation of the device. The SupStance VBR implant is a cage constructed of fused hollow cylindrical tubes with integral endcaps and open sides for introduction of bone graft material and bone reconstruction. The SupStance VBR cages are available in three diameters (22mm, 25mm, 28mm) and cover a range of heights from 35mm to 55mm with a total fixed sagittal angle of 5°.
The SupStance VBR cages are fabricated from poly-ether-ether-ketone (PEEK) and include markers made from titanium alloy. The implants are provided non-sterile and will be implanted via an antero-lateral approach.
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