90-832-02-05_07_11_Flyer_Bone_Cement_Kryptonite

CMF Surgery

Kryptonite™

Kryptonite™ Product Codes

A Bone Repair Product to Stick with

Kryptonite™ material has received a CE mark for use in Europe as a self-setting bone filler for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Kryptonite™ material is a resinous material for the repair of bony defects that may be shaped and gently applied to cranial defects.

Kryptonite™ material has regulatory clearance in Australia (TGA) and in Canada (Health Canada Approved).

Kryptonite™ material has obtained marketing authorization from the United States Food and Drug Administration as a bone cement with indications for use as a resinous material for filling cranial defects.

Manufactured by:

Item no.

Designation

52-702-05-04

Kryptonite™ Bone Cement, sterile, 5 cc

52-702-10-04

Kryptonite™ Bone Cement, sterile, 10 cc

52-702-15-04

Kryptonite™ Delivery Syringe, sterile, 10 cc

Doctors Research Group, Inc. 574 Heritage Road, Suite 202 Southbury, CT 06488 USA 1-203-262-9335 Made in the USA

Distributed by:

Contact your local representative for ordering or call +49-7461-706-0 to find a representative near you.

Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group Ludwigstaler Str. 132 · 78532 Tuttlingen · Germany Postfach 60 · 78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax +49 7461 706-193 info@klsmartin.com · www.klsmartin.com

07.11 . 90-832-02-05 . Printed in Germany © 2010 Doctors Research Group, Inc. Intended for International Distribution

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Adhesive

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Porous

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Bone-like Properties

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Low Exotherm

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Non-toxic

Kryptonite™ Bone Cement is non-toxic, with bone-like mechanical properties, and composed of naturally occurring fatty acids and calcium carbonate. The unique properties of Kryptonite™ Bone Cement make it well suited for cranial applications and distinguish it from PMMA and tricalcium phosphate/hydroxyapatite based products.

Adhesive Expansion during early polymerization drives the material into the porous structure and irregular topography of the bone, achieving a strong mechanical interlock.

PMMA - no bond Kryptonite™ Bone Cement - strong bond

Porous The polymerization process releases carbon dioxide, forming internal pores in the range of 50 to 300 µm in diameter and comprising approximately 50% of Kryptonite™ Bone Cement’s final volume.

Kryptonite™ Bone Cement can be mixed and delivered by hand or utilizing a number of commercially available mixing systems.

Bone-like Properties Kryptonite™ Bone Cement mimics natural bone in its mechanical properties (strength, stiffness), structure (porosity) and workability (drill, cut, burr).

Low Exotherm In contrast to PMMA products, Kryptonite™ Bone Cement exhibits a very low exotherm throughout the curing process. PMMA can exceed temperatures of 93°C during its curing cycle while Kryptonite™ Bone Cement cures at approximately 43°C. A low exotherm can substantially reduce the risk of local tissue necrosis during polymerization.

Patient presented with cranial defect after MVA. Kryptonite™ Bone Cement applied to defect in taffy state.

Non- toxic The biocompatibility, safety and stability of Kryptonite™ Bone Cement has been evaluated in accordance with FDA/ISO10993 guidelines and the product was found to be non-toxic and safe to use with no special precautions for either the patient or the operating room staff.

Image of pores

Kryptonite™ Bone Cement

PMMA

Specimens at ultimate compression failure