TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System, a Flowable Bio-Gel to Protect Healing Tissue and Preserve Function
HOUSTON, June 9, 2025 /PRNewswire/ — TYBR Health, a medical device and regenerative medicine company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the B3 GEL™ System. B3 GEL™ is a bioresorbable, flowable gel barrier designed to protect healing tissue planes and preserve mobility following surgeries involving tendons, ligaments, and skeletal muscle.
This clearance marks a significant milestone for TYBR Health, enabling a new approach to support functional recovery in musculoskeletal surgery. B3 GEL™ helps maintain surgical precision by temporarily separating tissues during the early healing phase—without impeding the natural healing process.
