Acuitive Technologies Gains FDA Clearance for CITRESPLINE and CITRELOCK Ligament Reconstruction

By Julie A. Vetalice

Acuitive Technologies Gains FDA Clearance for CITRESPLINE and CITRELOCK Ligament Reconstruction

Acuitive Technologies received FDA clearance to market CITRESPLINE™ and CITRELOCK™ Ligament Reconstruction Devices, manufactured with patented CITREGEN™ bioresorbable synthetic polymer.

CITREGEN releases molecules that support bone formation throughout its bioresorption process, leaving behind a biomimetic ceramic structure to be metabolized by the host tissue. This avoids the potential for bulk degradation and chronic inflammation.

The CITRESPLINE/CITRELOCK system is designed to firmly engage tendons and ligaments within a bone tunnel while preserving the integrity of the soft tissue during insertion of the device. Applications include orthopedic surgeries for fixation of ligament or tendon tissue repairs of the knee, shoulder, elbow, wrist, hand, ankle and foot.

Acuitive plans to commercialize the CITRESPLINE and CITRELOCK System with an orthopedic distribution partner.

This is the company's third 510(k) clearance since 4Q20, following the CITREGEN CITRELOCK Tendon Interference Screw and CITREFIX Knotless Suture Anchor.

"This FDA clearance for the CITRESPLINE and CITRELOCK system is a significant milestone that allows Acuitive to compete in the Sports Medicine Market using innovative materials and designs that protect the soft tissue during insertion while improving fixation strength," said Michael McCarthy, Managing Partner, Acuitive Technologies. "The CITRESPLINE/CITRELOCK System is the third innovation from our robust pipeline of CITREGEN based products that is cleared for commercialization in the U.S."

Product Labels: Traditional Soft Tissue Repair

Tags: 510(k) Clearance, Regulatory