Acuitive Technologies Granted FDA 510(k) Clearance for CITREFIX™ Knotless Suture Anchor
ALLENDALE, N.J., Feb. 11, 2021 /PRNewswire/ -- Acuitive Technologies today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CITREFIX™ Knotless Suture Anchor System with CITREGEN™ material technology, a new generation bioresorbable synthetic polymer. The CITREFIX system is intended to assist the attachment of tissue to bone during orthopedic surgeries such as fixation of ligaments or tendon graft tissue repairs of the shoulder, elbow, wrist, hand, knee, ankle, and foot extremities.
"This FDA clearance for the CITREFIX system is an important milestone for Acuitive," said Michael McCarthy, Managing Partner, Acuitive Technologies, Inc. "The CITREFIX Knotless Suture Anchor System expands our reach in both the Extremities and Sports Medicine Markets. It's the second innovative product from our robust pipeline that is cleared for commercialization in the U.S."
Inspired by nature, CITREGEN is a synthetic biomaterial purposefully designed on a molecular level to guide tissue regeneration by replicating the intrinsic cellular biochemical and structural support network. Its main component, citrate, is a naturally occurring anti-microbial and anti-inflammatory molecule that plays a crucial role in bone regeneration, where it regulates cellular metabolic processes and the formation of mineral structures. CITREGEN, the core material technology, releases molecules essential to bone formation throughout its bioresorption process leaving behind a biomimetic ceramic structure to be metabolized by the host tissue. This bioresorption process avoids the potential for bulk degradation and chronic inflammation. CITREGEN material technology is supported by an extensive licensed intellectual property (IP) portfolio from both Northwestern University and The Pennsylvania State University, following more than 15 years of academic research and five years of Acuitive proprietary development. Acuitive plans to commercialize the CITREFIX System in mid-year 2021 with an orthopedic distribution partner.
About Acuitive Technologies
Acuitive Technologies, founded in 2014 by four partners with decades of orthopedic experience and successes in multiple start-up companies that have introduced new technologies to the marketplace, is devoted to improving medical device performance and patient outcomes. By using transformative CITREGEN biomaterials, Acuitive intends to offer patients cost effective, tissue regenerative products for musculoskeletal injury and disease.
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SOURCE Acuitive Technologies