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Acuitive Technologies' Citrepore Receives FDA Clearance for Bone Void Filling

• Acuitive Technologies has received FDA 510(k) clearance for Citrepore, a synthetic bioactive bone void filler designed for orthopedic applications. • Citrepore's unique composition promotes natural bone healing by leveraging citrate, a key component in bone metabolism and formation. • The bone void filler features 80% porosity, facilitating the resorption of saline, blood, and bone marrow aspirate to support bone regeneration. • Citrepore is indicated for use in patients undergoing orthopedic surgery to aid in the natural bone healing process.

Acuitive Technologies Inc. has announced that it has received FDA 510(k) clearance for Citrepore, a synthetic bioactive bone void filler. The filler is designed to promote bone healing following orthopedic surgical procedures.
Citrepore is an osteoconductive and bioactive bone filler characterized by its 80% porosity, which facilitates the resorption of saline, blood, and bone marrow aspirate. This design is intended to promote natural bone healing in orthopedic patients.

Citrate's Role in Bone Metabolism

Richard Tran, PhD, Vice President of Research at Acuitive Technologies, emphasized the role of citrate in the filler's mechanism of action. "Citrate, a critical intermediate in the Krebs cycle, is highly concentrated in native bone and is closely associated with bone metabolism and formation," said Tran. "In response to citrate, human stem cells increase genetic signaling for metabolism, osteoinduction, osteoconduction, and extracellular matrix production."
The FDA clearance marks a significant step for Acuitive Technologies, providing a new option for orthopedic surgeons seeking to enhance bone healing in their patients.
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Reference News

[1]
Acuitive Technologies receives FDA 510(k) clearance of bioactive bone void filler - Healio
healio.com · Nov 23, 2024

Acuitive Technologies received FDA 510(k) clearance for Citrepore, a synthetic bioactive bone void filler promoting natu...

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