Orthopaedic trauma internal fixation systems

Worldwide, a fracture (broken bone) due to osteoporosis occurs every three seconds. This is in addition to sports injuries and accidents at work. In most cases, these fractures are treated surgically. The aim of such trauma treatment is to restore the broken bone to its correct position and alignment. If this is done with bone nails or bone plates, fixation systems are used to secure the bone in the anatomically correct position. Manufacturers of such fixation systems have to meet many stringent requirements in terms of functionality, accuracy, weight and appearance, while at the same time keeping an eye on the overall cost of the system due to increasing cost pressures.

These target systems, also known as "target arms" or "target devices", are subject to high demands. This starts with the forces exerted by the surgical technique on the system and therefore on the material. For example, they must be able to withstand rough handling as well as falls without plastic deformation. X-ray transparency and physiological harmlessness (biocompatibility) are also of fundamental importance. High targeting accuracy, even after many sterilisation cycles, together with very good resistance to chemical cleaning, make the target arms a high-tech product. Metals and epoxy resins have many disadvantages and it is difficult to meet all these requirements.

Composites hold the key to the future

We have a dedicated facility to meet these challenges and have been successfully manufacturing composite and stainless steel aiming devices and other surgical instruments for over 20 years. In addition to materials and manufacturing expertise, the site has an ISO 13485 quality management system and is FDA registered. In addition, Ensinger Medical's sales engineers assist customers in designing target devices to meet production requirements without compromising aesthetics. This Design For Manufacturing (DFM) approach reduces development time and costs for our customers.
Read more about composite machining for medical devices here.

For other target manufacturers looking for innovative solutions, we offer the TECATEC MT portfolio of highly suitable composite materials, which we also use in our own facilities.
In order for the holes for the screws to fix the plate or nail in the bone to be drilled with very high positioning accuracy, the insertion guides must not be subject to any plastic deformation. Accordingly, TECATEC PEEK MT CW50 black is characterised by very high mechanical parameters, especially in terms of specific strength and stiffness.

Our TECATEC PEEK MT CW50 black is also radio-transparent, allowing unrestricted x-ray imaging of the surgical area despite the target device. The material meets the specified requirements of the biocompatibility testing according to standard ISO 10993-1, -4, -5, -18 for contact of up to 24 hours with skin and tissue and, if applicable, indirect contact with blood.

The high glass transition temperature of 143°C, the low water absorption of the material and the very good chemical resistance result in very good sterilisation resistance and high thermal dimensional stability. As a result, high accuracy is maintained even after many hot steam sterilisation cycles.

Take a closer look here! By zooming and rotating, you can have a detailed look at the target arm.

Benefits

Safety during surgical intervention I: Proper anatomical position accuracy

Targeting / guiding arms made of our PEEK composite material make a significant contribution to safety during operations. One of the decisive factors in this case is the high implant anatomical position accuracy during the surgical procedure, resulting from the unusually high dimensional stability.

Safety During surgical intervention II: consistent biocompatibility

Consistent biocompatibility remains one of the most important requirements. As a result, all of our standard PEEK medical grade (MT) semi-finished plastic parts are tested according to ISO 10993. The biocompatibility test on the semi-finished part assists the user with performing the risk analysis and offers safety right from the product certification phase.

A clear view thanks to X-ray transparency

Implant delivery devices made of composites transparent to X-rays allow clear and unrestricted X-ray images of the surgical site to be taken during the procedure. The clear images permit reliable positioning and thus support an optimum outcome of the operation.

Low weight - easy handling.

Surgical interventions as part of trauma treatment call for force and accuracy in terms of the handling procedures involved. Lightweight implant delivery devices assist the surgeon with their work.

Thanks to their low specific weight, targeting / guiding arms made from TECATEC materials permit easier handling, which means they can be used effectively and economically during an operation.

Extended application lifetime

Using TECATEC materials, it is possible to achieve a high application time for the targeting arms in hospitals. TECATEC's excellent resilience to steam sterilisation permits a high number of sterilisation cycles, in some cases in excess of 500 cycles, thus reducing maintenance costs as well as repurchase costs for implant targeting systems.

Moreover, more instruments can be transported per tray, which means there are fewer trays in circulation, thereby shortening throughput times and offering further economic benefits.

Cost-effectiveness

Our Ensinger medical sales engineers work with you to produce the appropriate specification in the shortest possible time. Our goal: significant reductions in development time and costs for you.

COMPOSITES IN ORTHOPEADIC FIXING SYSTEMS

TECATEC PEEK MT CW50 black