REGULATORY INFORMATION
BIOLOX® Products
BIOLOX®delta and BIOLOX®forte conventional femoral heads and inserts, BIOLOX®OPTION, BIOLOX CONTOURA® and BIOLOX® DUO 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 authorities. Autophor®, Xenophor®, the first and the second BIOLOX® generations are not produced anymore. Products are not registered / available in all countries.
Information is provided for educational purposes. 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 authorities.
Caution: Dual mobility acetabular shells with BIOLOX®delta inserts are under development and are not approved by any authorities.
Caution: Knee implants made of BIOLOX®delta are either registered by CeramTec GmbH’s customers or are under development and not approved by any authorities.
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 are not commercially available. H1® is a registered trademark of Embody Limited. The ReCerf®, manufactured by MatOrtho Limited, is currently under an approved clinical MHRA investigation. The ReCerf® is registered by CeramTec’s customer only in Australia. ReCerf® is a registered trademark of MatOrtho Limited.
The H1® (Embody Ltd.) and the ReCerf® (MatOrtho Ltd.) ceramic hip resurfacing device are both undergoing a Clinical Investigations approved by the UK Health Research Authority.
Information is provided for educational purposes. 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. 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. 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 any authorities. 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. 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 authorities.
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 is 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.
The ReCerf® Hip Resurfacing Arthroplasty is made of BIOLOX®delta and is not approved by any authorities and is not commercially available. ReCerf® Hip Resurfacing Arthroplasty is in an MHRA, UK Health Research Authority, NHS approved clinical investigation. ReCerf® Hip Resurfacing Arthroplasty is also in a FAGG-approved clinical investigation in Belgium.
Information is provided for educational purposes. For product, safety, and risk information, always refer to the labeling of the legal manufacturer.
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 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. 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 authorities.
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 authorities.
Information is provided for educational purposes. For product, safety, and risk information, always refer to the labeling of the legal manufacturer.