High Quality Implants
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1 High Quality Implants Made by MONDEAL Hand Surgery
2 Introduction The human hand offers a variety of advanced features which enable us the implementation of special craftsmanship, artistic and emotional actions. This can be ensured only by perfect funktional interaction of structures such as bones, joints, muscles, tendons, nerves and blood vessels. Thus, the hand is one of the most complex organs of human being. The hand surgery is concerned with the diagnosis and treatment of acute or chronic injuries of the upper extremities (shoulder, upper arm, forearm, hand, finger, thumb). 2
3 MONDEAL Hand Surgery MONDE hand CONTOUR RADIUS 3
4 MONDE hand XS S CONTOUR Modular Hand-Osteosynthesis System M/L Our CONTOUR hand system is mostly used in the fields of osteosynthesis (traumatology), in the reconstructive surgery, as well as for the replantation of phalanx extremities. In addition, the CONTOUR system is very suitable for rheumatic diseases in the therapeutic surgery. The respective screws can be used for fixation of the plates and moreover as traction screws for the interfragmental compression osteosynthesis. All plates are horizontally pre-formed and do not, in most cases, need any further adaption. In addition, compression plates have been developed preventing slipping of bone during fixation by lateral stabilizers. Plates XS S Screws XS- and S- fixation plates for middle phalanx fractures Plates M Screws 2.3 L M-plates for proximal phalanx and I-V metacarpal bone (MC) fractures L-plates for I-V metacarpal (MC) fractures 4
5 MONDE hand PRP Palmar & Dorsal RADIUS Plating System DRP The palmar & dorsal RADIUS plating system is primarily used in traumatology, but also in elective reconstructive surgery. With our PRP & DRP, the entire spectrum of distal radius fractures can be surgically treated. In terms of handling, the systems are easy to implement and just as easy to remove. All screws can be used universally in both the PRP and DRP, involving the advantage that the majority of the required instruments are compatible with both systems. In addition, there are special instruments for the respective areas. All of the plates are anatomically preformed, the curved shape of the PRP plates ensures optimal cortical anchorage over the entire length. Our DRP system is minimally invasive usable and, in addition, provides intramedullary stabilization due to the special design of the plates. PRP DRP For the dorsal intramedullary plating area 5
6 MONDEAL Philosophy Customers Many of our customers rely on surgical and orthopedic systems, products and implants made by MONDEAL Medical Systems GmbH since years. The manufactured products are in great demand in many surgical and orthopedic applications of medical technology and have proven successfully. Advice Rely on our personal and experienced advice that enables a skillful implementation and realization of your ideas. We value on on-site customer support and direct contact to make sure you are in good hands. Take advantage of the flexible possibilities of our in-house construction, as well as the variable manufacturing and assembly methods. Flexibility The special internal structure of MONDEAL Medical Systems GmbH allows us to react to complex and individual requirements in order to fullfill these. By working together with selected partners, we are able to provide the surgical and orthopedic systems and implants at any time on schedule and in best quality without exception. Teamwork The close cooperation between the different business areas is only possible due to the individual strengths of each team member. Thanks to trainings and upgrade training courses, all staff members are skilled in their trade creating a solid foundation for advice and service. Teamwork and a good working environment are the basis for the implementation of the high standards of precision and quality set in all of our production processes. Only by being task-oriented, determined and with effective communication, the increasingly complex demands can be met. Because only together, goals can be achieved. Contact You would like to become acquainted with MONDEAL and our products? Please contact us: MONDEAL Medical Systems GmbH Am Gewerbering Mühlheim a. d. Donau/Germany Phone Fax mail@mondeal.de 6
7 MONDEAL Quality Highest demands on the quality of our products are a given as quality ensures reliability in use. Due to in-house development and in-house production, we can manage to achieve the set standards on quality and reliability in every working step. High Quality Implants MONDEAL implant systems are notable for highest quality of the materials used for the manufacturing of the products, as well as the feature of having graceful shapes with optimized characteristics in case of application. All products go through strict controls. Thus, for instance all screws have to be verified on surface character and accuracy of fit several times before leaving the factory to meet our high quality requirements. Construction, manufacturing and distribution of the company MONDEAL Medical Systems GmbH are certified according to DIN EN ISO This quality assurance system conforms to the requirements of the Annex II to Medical Devices Directive 93/42/EEC. In addition, it also meets the regulatory requirements of various countries around the world. High Quality Implants Made by MONDEAL Made by MONDEAL At our location in Mühlheim a.d. Donau near Tuttlingen, all modern requirements relevant to the construction, the manufacturing and the assembly of our products are available. The development of each product is supported by our engineers using the latest CAD technology. This e.g. enables a detailed 3D view of the prototype already in the design phase. The resulting and well-engineered products are realized by using modern CNC manufacturing technology, as well as the proven water jet technology preventing damage to the surface. The production process is completed by our assembly departments and own prototype and tool construction - implemented by highly motivated and qualified staff. The in-house production and therefore the harmonization of blade, screws and plate allow a perfect interaction of all components. Benefits of titanium for implants In general, pure titanium (DIN EN ISO /ASTM F67) is used for the manufacturing of bone plates while the titanium alloy Ti6Al4V (DIN EN ISO /ASTM F136) is used for the manufacturing of bone screws. Worldwide, these materials are used for short and long-term implants in the osteosynthesis for decades. For the following reasons: Completely biocompatible Corrosion-resistant Non-toxic in the biological environment Failure-free imaging with X-rays, computed tomography (CT) and magnetic resonance imaging (MRI) 7
8 High Quality Implants Made by MONDEAL We reserve the right to make catalog and design changes arising from further developments and modifications. Pictures, product descriptions and texts are the property of MONDEAL Medical Systems GmbH. Further use and reproduction by Third Parties requires written consent from MONDEAL Medical Systems GmbH. All rights reserved! Note: Responsibility for the selection of the patient, for adequate training as well as the decision as to the choice and use of the implants, a post-operative removal or retention of implants is the sole decision of the surgeon. All brands and logos referred to in this brochure, registered by Third Parties, are subject without restriction to the legal provisions currently in force and to the rights of ownership of the respective registered owner MONDEAL Medical Systems GmbH Am Gewerbering Mühlheim a. d. Donau/Germany Phone Fax mail@mondeal.de 97-F200-E Hand 01/09-13
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