www.fdanews.com/articles/201720-acuitive-technologies-gets-fda-clearance-for-ligament-reconstruction-systems
Acuitive Technologies Gets FDA Clearance for Ligament Reconstruction Systems
March 8, 2021
Acuitive Technologies has received 510(k) clearance from the FDA for its Citrespline and Citrelock ligament reconstruction systems.
The devices are designed to firmly engage tendons and ligaments within a bone tunnel while preserving the integrity of soft tissue during insertion. They use Citregen, a synthetic biomaterial designed to guide tissue generation using citrate, a natural anti-microbial and anti-inflammatory molecule that supports bone regeneration.
The two systems are intended for use in orthopedic surgeries for fixation of ligaments or tendon tissue repairs of the knee, shoulder, elbow, wrist, hand, ankle and foot.