REGULATORY INFORMATION

BIOLOX® Products

BIOLOX®delta and BIOLOX®forte conventional femoral heads and inserts, BIOLOX®OPTION, BIOLOX CONTOURA®, BIOLOX®DUO and the bicondylar knee implants made of BIOLOX®delta are registered by CeramTec's customers.

Products are not registered / available in all countries.

The BIOLOX®OPTION sleeves are not intended to be combined with regular BIOLOX®delta and BIOLOX®forte femoral heads. The use of sleeves and femoral heads is restricted to specific product ranges intended for this purpose. For all information related to the use and application of the sleeves in combination with the femoral heads, please always refer to the instructions for use of the legal manufacturer.

The H1® Anatomic Ceramic Hip Resurfacing made of BIOLOX®delta is in clinical investigation in the EU and UK by Embody Orthopaedic Ltd. The H1® is investigational device tested in a clinical study approved by MHRA and NHS, respectively. The H1® Anatomic Ceramic Hip Resurfacing is not approved by any authorities and not commercially available. This product is not cleared or approved by the FDA for distribution in the United States.

The H1® (Embody Ltd.) ceramic hip resurfacing device is undergoing a Clinical Investigation approved by the UK Health Research Authority.

Japan:

BIOLOX®DUO is registered by CeramTec‘s customers only in Japan.

USA:

BIOLOX®delta and BIOLOX®forte conventional femoral heads and inserts as well as BIOLOX®OPTION and BIOLOX CONTOURA® are registered in the United States by CeramTec's customers. These products are intended to be used in the United States as described in the product’s labeling of CeramTec’s customers. The bicondylar knee implants made of BIOLOX®delta are registered in the EU by CeramTec’s customers. These products are not cleared or approved by the FDA for distribution in the United States. Caution: All other shown implants (e.g. shoulder, hip resurfacing, direct-to-bone or ceramic foam products) are under development and are not approved by the FDA for distribution in the United States.

China:

CeramTec is not a registrant or legal manufacturer of medical devices under applicable laws for its BIOLOX® and DENSILOX® ceramic products which are not ready for use on any patient. All relevant medical devices are registered in relevant countries/regions by CeramTec’s customers.

 

Dental Products

DENSILOX® dental implants are registered by CeramTec’s customers in the USA, 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.

 

Veterinary Products

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

 

Information is provided for educational purposes. For product, safety, and risk information, always refer to the labeling of the legal manufacturer.