Success story Sternum ZipFix system made of PEEK

ZipFix only looks like an ordinary cable tie at first glance. The connectors are used to
close the sternum after open-heart surgery. Since the first surgery in February 2011, well
over 100,000 surgeries have been successfully performed worldwide.

In order to be able to manufacture the Zip-Fix, the needles for the ZipFix must be fed in
the clean room via an ultrapure water cleaning system and then overmoulded using the
injection moulding process. After injection moulding, the ZipFix fasteners are tested for
quality (e.g. tensile strength), laser marked and packaged according to customer
specifications. The final step is sterilisation by gamma rays according to EN ISO 11137.

The fact that all processes must be validated is state of the art and is not included in
any specifications. This is what customers require.

The success of the project is due on the one hand to the many years of toolmaking
know-how in the medical field and in the processing of PEEK, and on the other hand to
the possibility of carrying out all the production steps in one place under controlled
and validated conditions. This lowers the interface risk to practically zero and reduces
errors!