MatOrtho’s ReCerf hip resurfacing arthroplasty (HRA) has secured the CE mark, signifying its adherence to European safety and performance standards.
The certification enables broader access to hip resurfacing procedures, not only within the UK and Europe but also in other international markets where the CE mark facilitates market entry.
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Crafted from BIOLOX delta ceramic, the ReCerf HRA system addresses historical concerns related to metal-on-metal bearings by preserving the natural bone of an individual.
This material is known for its high biocompatibility, hypoallergenic properties, and wear resistance, which make it safe to use in terms of metal ion release.
The product, which is the first commercially available ceramic HRA worldwide, secured approval from Australia’s Therapeutic Goods Administration in November 2024.
MatOrtho founder Mike Tuke said: “This is more than a regulatory milestone. It represents two decades of focused effort to improve hip resurfacing through an advanced material.
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By GlobalData“That became a possibility with BIOLOX delta and cooperation with CeramTec, which led in stages to ReCerf – an all-ceramic resurfacing implant that is already delivering excellent results. We’re proud to make this more widely available to specialist hip resurfacing surgeons and patients who want to stay active.”
Since its first usage in 2018, ReCerf has been used in more than 1,600 individuals, with reports of positive outcomes and a very low revision rate up to six years.
MatOrtho noted that a peer-led surgeon training programme is underway to guarantee the safe and effective use of the system.
In addition to the CE mark, the ReCerf has been listed by Australia’s Prostheses List Advisory Committee (PLAC). This listing means that the device can be accessed by patients through private health insurance in the country.
