In the extremely rare event of the fracture of a BIOLOX® femoral head, the BIOLOX®OPTION system can be used for a revision with the prosthesis stem left in situ. In such a case, the Instructions for Use of the BIOLOX®OPTION system must be followed. When a plastic insert is present, it must also be removed and replaced, even if it is well fixed. In the extremely rare event of the fracture of a ceramic component, a synovectomy must be performed whenever appropriate. In this case, a combination of metal (ball head) with plastic (insert) as well as metal with metal is contraindicated in a revision.
No. There is no known clinical evidence indicating the occurrence of adverse reactions directly related to BIOLOX®forte material. The biocompatibility of BIOLOX®forte ceramics according to DIN ISO 10993-1 has been verified. Pathogenic reactions to BIOLOX®forte particles at clinically relevant concentrations are not known.
CeramTec’s DIN ISO 13485:2016 can be downloaded here.
CeramTec holds numerous quality system standard certifications. Besides EN ISO 9001, which covers a wide scope of activities in all areas, CeramTec’s Quality Management System is certified by the German Notified Body MDC medical device certification GmbH according to EN ISO 13485, which is specifically intended to be used in the field of medical devices.
BIOLOX® components are registered by CeramTec’s customers, the implant manufacturers of the entire endoprosthesis system. Please contact an implant manufacturer if you are looking for a ceramic solution in your country.
All BIOLOX® components are produced in our facilities in Germany.
CeramTec (previously Feldmühle and Cerasiv) has been producing BIOLOX® ceramic hip components since 1974. BIOLOX®forte components were introduced in 1994 and BIOLOX®delta components in 2003.
The H1 Hip Resurfacing system by Embody is currently being evaluated in clinical trial. For more details, please contact Embody here.
ReCerf® by MatOrtho is not yet on general release with CE approval and its availability around the world is subject to local, regulatory and hospital approvals. For more details, please contact MatOrtho via email.
Extensive tests and retrieval investigations have shown that the use of ceramic femoral heads such as BIOLOX® mitigate the risk of fretting corrosion.
Extensive tests and retrieval investigations support the use of the BIOLOX®OPTION system in revision. According to studies, fretting and corrosion is of no concern with BIOLOX®OPTION heads.
Please follow the instructions for use of the implant manufacturer of the endoprosthesis system implanted.
Please follow the instructions for use of the implant manufacturer of the endoprosthesis system implanted.
BIOLOX®delta component fractures are extremely rare. According to registry data and scientific literature, 1 up to 10 out of 100,000 heads and 1 up to 10 out of 10,000 inserts have to be revised for fracture.
For comparison about 4,000 out of 100,000 hip replacement implants have to be revised due to other reasons (e.g. periprosthetic fracture, recurrent dislocation, aseptic loosening, infection…)
References available on demand at CeramTec.
Yes, BIOLOX®forte ceramic is hypoallergenic.
In the extremely rare event of the fracture of a ceramic component, a synovectomy has to be performed whenever appropriate. In this case, a combination of metal (ball head) with plastic (insert) as well as metal with metal is contraindicated in a revision.
According to current literature, the incidence of squeaking ranges from 0% to 23%, but the squeaking rates in most of the clinical studies are below 3%. References available on demand at CeramTec GmbH.
Noise generated during movement after a BIOLOX® insert has been implanted is not sufficient to indicate a malfunction or change in the performance of the endoprosthesis system. However, it is recommended to check the integrity of the endoprosthesis system.
Find more information in the following literature: Practical Guide for Handling Noises in Hard-on-Hard Bearings
Squeaking is mostly infrequent, benign and not associated with pain or functional limitation. Studies show that squeaking is generally not bothersome to patients.
Find more information in the following literature: Practical Guide for Handling Noises in Hard-on-Hard Bearings
From the tribological point of view, BIOLOX®forte, BIOLOX®OPTION and BIOLOX®delta femoral heads may only be used in combination with BIOLOX®forte or BIOLOX®delta inserts or PE or XPE inserts in combinations specifically designed by the implant manufacturers in cooperation with CeramTec and approved/cleared by the authorities for this combination.
BIOLOX®forte, and BIOLOX®delta inserts may only be used with BIOLOX®forte, BIOLOX®delta, and BIOLOX®OPTION femoral heads designed by the implant manufacturers in cooperation with CeramTec and approved/cleared by the authorities for this combination. Other combinations of articulating materials are not permitted. Regulatory guidelines as well as the instructions for use of the implant manufacturers in this regard must always be followed.
From the tribological point of view, BIOLOX®forte, BIOLOX®OPTION and BIOLOX®delta femoral heads may only be used in combination with BIOLOX®forte or BIOLOX®delta inserts or PE or XPE inserts in combinations specifically designed by the implant manufacturers in cooperation with CeramTec and approved/cleared by the authorities for this combination. BIOLOX®forte, and BIOLOX®delta inserts may only be used with BIOLOX®forte, BIOLOX®delta, and BIOLOX®OPTION femoral heads designed by the implant manufacturers in cooperation with CeramTec and approved/cleared by the authorities for this combination. Other combinations of articulating materials are not permitted. Regulatory guidelines as well as the instructions for use of the implant manufacturers in this regard must always be followed.
A BIOLOX® femoral head may only be combined with a prosthesis component released by the legal manufacturer of the endoprosthesis system for combination with a BIOLOX® femoral head and for which there is a corresponding approval by the competent authority. The instructions of the respective endoprosthesis system including the BIOLOX® femoral headmust be followed.
Implanting surgeons must always refer to the THA system-specific instructions for use, recommendations and possible tools for liner extraction that are provided by the legal manufacturer of the THA system.
Alternative methods for extracting a ceramic liner have been described in the literature. Feel free to contact our team if you would like us to share our literature summary.
In the extremely rare event of the fracture of a BIOLOX® femoral head, the BIOLOX®OPTION system can be used for a revision with the prosthesis stem left in situ. In such a case, the Instructions for Use of the BIOLOX®OPTION system must be followed. When a plastic insert is present, it must also be removed and replaced, even if it is well fixed. In the extremely rare event of the fracture of a ceramic component, a synovectomy must be performed whenever appropriate. In this case, a combination of metal (ball head) with plastic (insert) as well as metal with metal is contraindicated in a revision.
In the extremely rare event of the fracture of a ceramic component, a synovectomy has to be performed whenever appropriate. In this case, a combination of metal (ball head) with plastic (insert) as well as metal with metal is contraindicated in a revision.
No. BIOLOX®OPTION system may only be combined with a prosthesis component released by the legal manufacturer of the endoprosthesis system for combination with a BIOLOX®OPTION system and for which there is a corresponding approval by the competent authority. The instructions of the respective endoprosthesis system including the BIOLOX®OPTION system must be followed.
The BIOLOX®OPTION system is part of the endoprosthesis system. The indications, contraindications and recommendations for use of the endoprosthesis system must be followed.
A used BIOLOX® femoral head poses risk of damage potentially invisible to the naked eye. Since any kind of damage can adversely affect the ceramic’s functionality and/or stability, safe use cannot be ensured. Any alteration of the bearing surface (e.g. points of impact or metal deposition) could potentially cause excessive wear leading to complications.
The BIOLOX® femoral head must be fixed on the stem taper by using slight axial pressure and twisting at the same time.
Afterwards, the plastic head impactor must be placed on the pole of the BIOLOX® femoral head, and with one or several moderate strikes of the hammer on the plastic head impactor in alignment with the ball head axis, the BIOLOX® femoral head is fixed on the stem taper.
Caution: A BIOLOX® ball head must never be directly struck with a hammer. Only the plastic head impactor provided for this purpose by the legal manufacturer of the respective endoprosthesis system may be used.
Please refer to the IFU of the implant manufacturer.
BIOBALL® is the revision head system offered by Merete GmbH. BIOBALL® heads are made either of metal or of BIOLOX®delta ceramic.
BIOLOX®OPTION is the ceramic head revision system offered by CeramTec to other implant manufacturers. Heads and adapters of both systems are not compatible and must not be mixed.
You can select between sand‐blasting, acid‐etched surface treatment or even surface texturing, depending on your requirements.
Yes, you can benefit from our proprietary feedstock developed in‐house to achieve the highest level of differentiation. (DENSILOX®)
We have a 100% manufacturing depth starting from the raw material, powder preparation, shaping including sintering and hipping, different types of surface treatment as well as quality inspection and different types and ways of packaging.
Challenge us to help you reach your desired level of product differentiation.
Yes, our ceramic expertise and more than 30 years of experience allow for the shaping and manufacturing of ceramic‐friendly designs of monobloc and even two‐piece implants with technically challenging design features. (DENSILOX®)
CeramTec Medical applies a range of manufacturing technologies depending on the volume and complexity of your component: standard green machining (before sintering), hard machining (after sintering), ceramic injection moulding (CIM) or a combination of CIM and hard machining.
All DENSILOX® components are developed, manufactured, tested and packed by CeramTec Medical in our manufacturing facilities in Germany.
You can choose DENSILOX® ceramics in a range of colors for an individual solution: natural white, ivory or “gingiva pink.”
All DENSILOX® ceramic implants and abutments are made of 100% metal‐free and biocompatible oxide‐based materials. You can select according to your requirements between Zirconia (TZP), Alumina Toughened Zirconia (ATZ), and Zirconia Toughened Alumina (ZTA) ceramics.
All DENSILOX® ceramic implants and abutments from CeramTec Medical are certified under the international standards of EN ISO 13485 to ensure the highest quality standards while incorporating health and safety aspects into all our processes.
All implants made of DENSILOX® ceramics are class IIb implants (in the EU), manufactured and 100% inspected in our manufacturing facilities in Germany.
Yes. The CleanImplant Foundation has highlighted the importance of impurity and contaminant‐free dental implants prior to sterilization. CeramTec Medical partners with the CleanImplant Foundation to introduce and fulfil new standards for implant suppliers. CeramTec’s DENSILOX® customised dental solutions produced in our facilities in Germany are certified by the German CleanImplant Foundation with the 2023 CleanImplant supplier label.
BIOLOX CONTOURA® has been cleared by the FDA for clinical use in the United States. It is registered by CeramTec’s customer. It is not approved yet in the EU or any other countries.
Unfortunately, CeramTec cannot deliver customized sleeves. Please contact Merete GmbH via email who may be able to support you in such a case.
Yes, CeramTec Medical offers sterile packaging to dental implant partners as an additional service option.
No. CeramTec tests and assesses the geometry and the compatibility of the BIOLOX®OPTION sleeve with the BIOLOX®OPTION head of each relevant implant manufacturer. Both components are part of a system and must not be mixed.
BIOLOX®OPTION heads can be used in both primary and revision surgeries. Please contact an implant manufacturer to check the indications.
Yes. For example, the BPK S system by PETER BREHM is a metal-free bicondylar implant made of BIOLOX®delta. Please contact PETER BREHM here.
The sleeve adapter is composed of titanium alloy (Ti6Al4V).
There are no known restrictions for using MRI diagnostic tools with ceramics in Total Hip Replacement. Ceramics have shown a superior imaging quality in comparison with metal implants (i.e., smaller and fewer artifacts). Please always refer to the labeling of the implant manufacturer.
A BIOLOX®delta head may only be re-sterilized in exceptional cases, and then only by the legal manufacturer of the respective endoprosthesis system after consulting with CeramTec, as only the legal manufacturer of the endoprosthesis system is capable of adhering to the process steps and parameters necessary for achieving successful sterility and preventing possible impairment of the ceramic.
CeramTec generally does not recommend re-sterilization of BIOLOX® components. Re-sterilization by hospitals is always prohibited (e.g. autoclave, steam sterilization, especially).
Yes. BIOLOX®delta ceramic is hypoallergenic.
- Thomas P, Stea S. Metal Implant Allergy and Immuno-Allergological Compatibility Aspects of Ceramic Materials. Heidelberg, Germany: Springer-Verlag Berlin Heidelberg; 2015.
- Bergschmidt P, Bader R, Ganzer D, et al. Ceramic femoral components in total knee arthroplasty - two year follow-up results of an international prospective multi-centre study. Open Orthop J. 2012;6:172-178. doi:10.2174/1874325001206010172.
No. There is no known clinical evidence indicating the occurrence of adverse reactions directly related to BIOLOX®delta material. BIOLOX®delta does not release toxic metal ions. The biocompatibility of BIOLOX®delta ceramics according to DIN ISO 10993-1 has been verified. Pathogenic reactions to BIOLOX®delta particles at clinical relevant concentrations are not known.
Chromia is completely dissolved in the alumina matrix and gives BIOLOX®delta its characteristic pink color.
BIOLOX®delta is an alumina matrix ceramic composite composed of alumina, zirconia and the additives strontia, yttria and chromia.
There are no known restrictions for using MRI diagnostic tools with ceramics in Total Hip Replacement. Ceramics have shown a superior imaging quality in comparison with metal implants (i.e., smaller and fewer artifacts). Please always refer to the labeling of the implant manufacturer.
A BIOLOX®forte head may only be re-sterilized in exceptional cases, and then only by the legal manufacturer of the respective endoprosthesis system, as only the legal manufacturer of the endoprosthesis system is capable of adhering to the process steps and parameters necessary for achieving successful sterility and preventing possible impairment of the ceramic material. Any re-sterilization by the legal manufacturer should first be discussed with CeramTec.
CeramTec generally does not recommend re-sterilization of BIOLOX® components. Re-sterilization by hospitals is always prohibited (e.g., especially autoclave, steam sterilization,).
