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
■
Adhesive
■
Porous
■
Bone-like Properties
■
Low Exotherm
■
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