REGULATORY INFORMATION

BIOLOX®delta and BIOLOX®forte conventional femoral heads and inserts as well as BIOLOX®OPTION are registered by CeramTec's customers. BIOLOX CONTOURA® is registered in the USA by CeramTec’s customers. The bicondylar knee implants made of BIOLOX®delta are registered in the EU by CeramTec’s customers. BIOLOX®DUO is registered by CeramTec‘s customers only in Japan. The products are not registered / available in all countries.

Caution: All other shown implants (e.g. shoulder, spine, H1 hip resurfacing, direct-to-bone or ceramic foam products) are under development and are not approved by any authorities.

DENSILOX® dental implants are registered by CeramTec’s customers in the EU and Switzerland. ZERAMEX® dental implants are registered by Dentalpoint AG. The ceramic foam used for dental components is under development and is not approved by any authorities.

VERILOX® implants are not for human but only for veterinarian use and are not approved by any authorities.

 

Regulatory Information CeraNews: 

The H1® Anatomic Ceramic Hip Resurfacing made of BIOLOX®delta is in clinical investigation in the EU and UK by Embody Orthopaedic Limited. The H1® is investigational device tested in a clinical study approved by MHRA and NHS, respectively. The ReCerf®, manufactured by MatOrtho Limited, is currently under an approved clinical MHRA investigation. The H1® Anatomic Ceramic Hip Resurfacing and the ReCerf® are not approved by any authorities and are not commercially available.