CeramTec GmbH

BIOLOX® ceramics are considered a benchmark in ceramic joint replacement.

All of the world’s leading orthopedic manufacturers offer hip joint replacement systems featuring BIOLOX® ceramic components. No other manufacturer’s material is used as often for hip bearing couples as the pink BIOLOX®delta ceramics.

20 Years Together —

That's What Has Driven Us

Discover the History of BIOLOX®delta

At CeramTec we can proudly look back on more than 45 years of experience in the development and manufacturing of innovative ceramic solutions for medical applications.

Our material has developed from BIOLOX®, established in 1974, to BIOLOX®delta introduced in 2003.

FDA Clearance for BIOLOX®delta

The use of BIOLOX®delta ceramic heads was first granted by the FDA in 2003. BIOLOX®delta unlocked the potential and possibility of complex geometries and innovations that had not been achievable until now.

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Introduction of BIOLOX®OPTION

The BIOLOX®OPTION ceramic sleeved femoral head offers the possibility of not only adjusting offset intraoperatively, but also revising a femoral head implant while retaining a well-fixed femoral stem with minor damage on the taper surface. The adapter sleeve is designed to create a pristine taper interface for the ceramic head before it is placed on a stem in situ.

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Innovation Continues - Ceramic Foam

An exciting new technology currently under development is the manufacturing of ceramic components with an open porous surface – ceramic foam.

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FDA Breakthrough Device Designation

The U.S. Food & Drug Administration (FDA) has confirmed that CeramTec’s novel ceramic total knee replacement device and proposed indication for use meet the criteria of a Breakthrough Device. The designation as a Breakthrough Device by the regulatory authority is an encouraging signal to CeramTec.

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Highly Biocompatible and Hypoallergenic

BIOLOX®delta is a highly biocompatible and hypoallergenic ceramic material. It shows superior physico-chemical properties leading to excellent wettability and a very high wear resistance. It is safe in terms of metal ion release and pathogenic reactions to ceramic particles are highly unlikely. Citations for all statements below can be found here.

Clinical Outcomes

The use of ceramic bearings in hip arthroplasty has increased over the last years. By now, BIOLOX®delta is the preferred femoral head material in hip replacements. Most arthroplasty registries from all over the world confirm that the use of ceramic heads is associated with lower rates of revision compared to metal heads.

Impact on the clinical outcome

Metal Hypersensitivity

BIOLOX®delta ceramic is hypoallergenic and is safe in terms of metal ion release. Due to the nature and strength of the covalent and ionic bonds of its structure, BIOLOX®delta ceramic demonstrates high chemical stability in physiological environments.

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Infection

BIOLOX®delta ceramic has higher wettability, protein adsorption, and reduced incidence of bacterial adhesion compared to CoCr and other materials. The most recent registry data show that (mixed) ceramic bearings are associated with a lower risk of revision for PJI compared to metal bearings.

Use in Revisions

Sleeved ceramic heads such as BIOLOX®OPTION offer the possibility of revising a femoral head implant while retaining a well-fixed femoral stem with minor damage on the taper surface. The BIOLOX®OPTION system has proven to be safe and is reliable in revisions for ALTR. Extensive tests and retrieval studies show that the use of an adapter sleeve has no significant effect on the corrosion of modular taper connections.

Cost-Effectiveness in THA

Studies that have examined the cost effectiveness of different bearing-materials and analyzed the relation between initial cost and long-term benefit of the bearing have shown that ceramics are associated with a high potential for cost-savings in THA, therefore may constitute an economical advantage.

What is a cost-effective solution in THA?

Information to Download

Read now or save for later - our compact PDF files provide you with the most important facts:

BIOLOX® Hip Components Development Line, download

BIOLOX® Generations of Ceramic Materials, download

BIOLOX®delta Quick Reference Guide, download

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