Implants & Osteosynthesis

Implants and osteosynthesis systems — plates, screws, nails, endoprostheses and patient-specific components — place the highest demands in the entire industry on material, manufacturing and documentation. The materials processed are chiefly titanium Grade 5 and Grade 23, implant steels to ISO 5832 and, increasingly, PEEK and ceramics. Production calls for validated processes from machining through surface treatment (anodising, blasting, polishing) to cleanroom assembly and sterile packaging.

Anyone searching the register for implant suppliers typically filters along three axes: the approved materials together with batch traceability, the cleanroom class for assembly and packaging to ISO 14644-1, and the regulatory reach — ISO 13485 is a basic requirement, while MDSAP and FDA registration determine access to markets outside Europe. With contract manufacturers there is the further question of whether they act purely as a subcontract manufacturer or as legal manufacturer with their own CE marking.

The category covers both those placing complete systems on the market and specialist suppliers manufacturing to customer drawings — from the prototype with initial sample inspection report to validated series production. In the Tuttlingen area and in Switzerland in particular, a dense chain of manufacturing specialists has established itself that can handle batch sizes from 25 pieces economically.