Orthofix’s OsteoCove graft receives US FDA 510k clearance

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Orthofix Medical has secured the 510k clearance from the US Food and Drug Administration (FDA) for its advanced bioactive synthetic graft, OsteoCove, for use in spine and orthopaedic procedures.

The company also announced the full commercial launch of the graft, which has been formulated to provide superior bone-forming capabilities to support a wide range of spine and orthopaedic procedural applications.

OsteoCove is developed from a blend of β-tricalcium phosphate (ß-TCP) and hydroxyapatite (HA), along with type-I bovine collagen.

It has a granule surface structure specifically engineered to stimulate a bone-forming response, as demonstrated by its ability to grow bone in a muscle pouch model.

The surface chemistry and microporosity of OsteoCove foster bone formation, surpassing the performance of other comparable commercially available advanced synthetic grafts.

Orthofix chief scientific officer Dr Frank Vizesi said: “Using the same disciplined R&D approach we have historically taken with our internally processed demineralised bone matrix solutions, we created a product that challenges the performance expectations of typical synthetic bone graft substitutes.

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“OsteoCove is another prime example of leveraging our strengths in product development in combination with our vertically integrated manufacturing expertise.”

Orthofix global biologics president Tyler Lipschultz said that the launch of OsteoCove synthetic graft significantly strengthens the company’s biologics portfolio.

Lipschultz added: “With the introduction of OsteoCove, we expect strong growth in this large market segment as we continue to deliver on our commitment to provide surgeons a comprehensive offering of biologic solutions to meet the needs of their patients.”

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• Source: https://www.medicaldevice-network.com/news/orthofixs-osteocove-graft-510k/