Orthopaedic trauma internal fixation systems

The goal of orthopaedic trauma treatment is to restore a fractured bone to its correct position and orientation. When this is done by means of surgical intervention, fixation systems are used to secure the bone in the anatomically correct position.

Manufacturers of such internal fixation systems need to meet many and exacting requirements in terms of function, weight and appearance, at the same time as keeping an eye on the overall costs in view of increasingly tight budgets.

Internal fixation systems, also referred to casually as "targeting arms" / "guiding arms", are subject to demanding requirements. This starts with the forces acting on the system, and thus also on the material, resulting from the operation technique. Accordingly, it needs to withstand rough handling as well as falls without undergoing plastic deformation. Moreover, X-ray transparency as well as physiological harmlessness (biocompatibility) are of fundamental importance. The guaranteed hit rate, even after many sterilisation cycles, in parallel with chemical cleaning, makes the targeting arm ultimately a high-end product. Metals as well as epoxy resins have many disadvantages and have great difficulty coping with all these requirements.

Composites hold the key to the future

We offer outstandingly suitable composite materials for manufacturers of trauma internal fixation systems looking for innovative solutions, in the form of the TECATEC MT portfolio.

To ensure the positional accuracy of the screws for fixing the plate or the nail to the bone, the so called targeting or guiding arm is not allowed to undergo any plastic deformation. Consequently, TECATEC PEEK MT CW50 black is characterised by its very high mechanical values, in particular regarding dimensional and torsional stability. Moreover, the material has good haptic properties, and possess only slight internal stresses, if processed correctly.

In addition to this, TECATEC PEEK MT CW50 black is X-ray transparent, which means that even when the implant delivery device is placed in position it is possible to take an X-ray of the operation area without any restrictions. Furthermore, this material has been tested for biocompatibility according to ISO 10993 for up to 24 hours contact time (as is the case with all our standard Medical-Grade (MT) semi-finished products). Even if contact with the patient is of short duration (including inadvertent contact), any negative physiological effect from the composite material is absolutely ruled out.

The high glass transition temperature and low water absorbency of this PEEK composite, as well as its very good chemical resistance, results in excellent ability to withstand sterilisation. Consequently, absolute proper anatomical position accuracy continues to be ensured even after many sterilisation cycles, and even when hot steam sterilisation is used.

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

The specially designed materials of Ensinger's TECATEC composite family offer extreme mechanical strength and thermal dimensional...