Medical devices created in CARE receive FDA clearance

Above: CITRELOCK tendon fixation devices. Credit: Acuitive Technologies
The Center for Advanced Regenerative Engineering, led by its director Guillermo Ameer, has pioneered an innovative orthopedic medical device fabricated from a novel biomaterial, and has received clearance from the U.S. Food and Drug Administration (FDA) for use in surgeries to attach soft tissue grafts to bone.
The biomaterial is the first thermoset biodegradable synthetic polymer ever approved for use in an implantable medical device. Ameer’s biomaterial, called CITREGEN™, helps grafted tissues heal by recreating their intrinsic biochemical and structural support network. CITREGEN™ is the core material technology in the CITRELOCK™ Interference Screw System, which will be produced and marketed by Acuitive Technologies, Inc. The system is intended for soft tissue attachment or fixing ligaments and tendon graft tissue in joint surgeries. “CITREGEN is an unprecedented and innovative bioresorbable biomaterial technology developed to support the body’s normal healing process and promote tissue regeneration,” Ameer said. “When used to fabricate devices for reconstruction of tissues, such as ligaments, blood vessels, bladder and bone, results have been impressive and beyond our expectations.”
Read the full story about the device as covered by Northwestern News.
The CITRELOCK Interference Screw System will become available through Acuitive’s orthopaedic distribution partner in early 2021. Read more about Acuitive's FDA Clearance in this release.
February 15, 2021

Above: CITREFIX™ Knotless Suture Anchor System
On February 11, 2021, Acuitive Technologies announced a second product that uses CITREGEN™ material technology has also received FDA clearance. The CITREFIX™ Knotless Suture Anchor 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. Read more about the product and announcement here.
March 4, 2021

Above: CITRESPLINE/CITRELOCK™ System
Acuitive Technologies, Inc. announced on March 4, 2021, U.S. Food and Drug Administration (FDA) approval of a third device designed using the core material technology CITREGEN™, pioneered by Dr. Guillermo Ameer and his lab.
The CITRESPLINE/CITRELOCK™ system is intended to firmly engage tendons and ligaments within a bone tunnel while preserving the integrity of the soft tissue during insertion of the device. These products are intended to be used during orthopedic surgeries for fixation of ligament or tendon tissue repairs of the knee, shoulder, elbow, wrist, hand, ankle, and foot. Acuitivie Technologies, Inc. intends to commercialize the CITRESPLINE and CITRELOCK System with an orthopedic distribution partner to compete in the Sports Medicine market.
Read the full press release by Acuitive Technologies, Inc. here.
Learn more about CITREGEN™ technology.