CITREPORE Synthetic Bioactive Bone Void Filler Receives FDA 510(k) Clearance
In a November 12th press release, Acuitive Technologies Inc. announced that CITREPORE, “a unique synthetic bioactive bone void filler”, has received FDA 510(k) clearance to enter the market.
CITREPORE is the latest musculoskeletal implant fabricated with CITREGEN biomaterial technology, which uses a biodegradable synthetic citrate polymer developed by Professor Guillermo Ameer’s laboratory. Incorporating citrate, phosphate, and calcium vital to bone regrowth, CITREGEN-based products provide initial structural requirements and a pro-regenerative microenvironment to the implant, steadily releasing citrate that supports bone regeneration. After placement in the bony void, CITREPORE is resorbed predictably and replaced by the patient’s natural bone.
CITREPORE is designed with flexibility in mind. Rather than a single one-size-fits-all component, CITREPORE can be shaped, cut, and fit to small gaps in a patient’s bone structure. The implant reduces chronic inflammation and promotes bone and tissue regrowth in the area.
CITREPORE is Acuitive Technologies’ sixth product to receive FDA 510(k) clearance, all using the citrate-based biomaterial technology pioneered by the Ameer Lab (CITREGEN line). The CITRELOCK tendon fixation device and CITREFIX knotless suture anchor are currently marketed by Stryker Corporation.