REGULATORY INFORMATION
BIOLOX® Products
BIOLOX®delta and BIOLOX®forte conventional femoral heads and inserts, BIOLOX®OPTION, BIOLOX®CONTOURA, BIOLOX®DUO, and dual mobility constructs with BIOLOX®delta conventional femoral heads and BIOLOX®delta XLWzero inserts are registered by CeramTec GmbH’s customers. Knee implants made of BIOLOX®delta are either registered by CeramTec GmbH’s customers or are under development and not approved by any regulatory authority or notified body . Autophor®, Xenophor®, the first and the second BIOLOX® generations are no longer produced. Products are not registered / available in all countries.
Information is provided for educational purposes only. For product, safety, and risk information, always refer to the labeling of the legal manufacturer.
Caution: All other shown implants (e.g., shoulder, spine, hip resurfacing, direct-to-bone or ceramic foam products) are under development and are not approved by any regulatory authority or notified body.
Caution: Knee implants made of BIOLOX®delta are either registered by CeramTec GmbH’s customers or are under development and not approved by any regulatory authority or notified body.
The H1® Anatomic Ceramic Hip Resurfacing is made of BIOLOX®delta, manufactured by Embody Orthopaedic Limited, and is in clinical investigation in the EU and UK, approved by MHRA and NHS. The implants of the H1®are registered by CeramTec GmbH’s customer only in the EU. H1® is a registered trademark of Embody Orthopaedic Limited.
The ReCerf® Hip Resurfacing Arthroplasty is made of BIOLOX®delta, manufactured by MatOrtho Limited, and is in a clinical investigation in the UK, approved by MHRA. The ReCerf® is registered by CeramTec GmbH’s customer only in Australia. ReCerf® is a registered trademark of MatOrtho Limited.
Products are not registered / available in all countries.
Information is provided for educational purposes only. For product, safety, and risk information, always refer to the labeling of the legal manufacturer.
Japan:
BIOLOX®DUO is registered by CeramTec GmbH‘s customers only in Japan.
Information is provided for educational purposes only. For product, safety, and risk information, always refer to the labeling of the legal manufacturer.
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. Dual mobility constructs with BIOLOX®delta conventional femoral heads and BIOLOX®delta XLWzero inserts are registered by CeramTec GmbH’s customers and are not cleared or approved by the FDA for distribution in the United States. Knee implants made of BIOLOX®delta are either registered by CeramTec GmbH’s customers in the EU or are under development and not approved by anyregulatory authority or notified body. 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.
Information is provided for educational purposes only. For product, safety, and risk information, always refer to the labeling of the legal manufacturer.
Caution: Devices shown (knee and resurfacing products) have been granted Breakthrough Device designation. These devices have no marketing authorization and are not cleared or approved by the FDA for distribution in the United States. The BIOLOX® CERAMIC KNEE is under development and is not approved by any regulatory authority or notified body.
Information is provided for educational purposes only. For product, safety, and risk information, always refer to the labeling of the legal manufacturer.
China:
CeramTec GmbH is not a registrant or legal manufacturer of medical devices under applicable laws for its BIOLOX® and DENSILOX® ceramic products which are not ready to use on any patient. All relevant medical devices are registered in relevant countries/regions by CeramTec’s customers.
Information is provided for educational purposes only. For product, safety, and risk information, always refer to the labeling of the legal manufacturer.
Dental Products
DENSILOX® dental implants are registered by CeramTec GmbH’s customers in the USA, EU and Switzerland. ZERAMEX® dental implants are registered by CeramTec Schweiz GmbH. The ceramic foam used for dental components is under development and is not approved by any regulatory authority or notified body.
Information is provided for educational purposes. For product, safety, and risk information, always refer to the labeling of the legal manufacturer.
Veterinary Products
VERILOX® implants are not for human but only for veterinarian use and are not approved by any regulatory authority or notified body.
Information is provided for educational purposes only. For product, safety, and risk information, always refer to the labeling of the legal manufacturer.