Atreon Orthopedics Receives FDA Clearance for Rotator Cuff Regeneration Device

By Julie A. Vetalice

Atreon Orthopedics received FDA 510(k) clearance to market the Rotium™ Bioresorbable Wick for use in rotator cuff repair.

Rotium is a synthetic bioresorbable scaffold. Inserted between a repaired tendon and bone, it acts as a facilitator to enhance tendon healing. Animal study of acute and chronic models has demonstrated an improvement in tendon strength from repairs using Rotium vs. without the device.

Atreon Orthopedics is a subsidiary company of ParaGen Technologies, which is itself a joint venture between Nanofiber Solutions, the technology developer, and Ikove Venture Partners, which provides full operational support, market strategy and access to funding via a global network of investors.

Source: Atreon Orthopedics

Product Labels: Orthobiologic Soft Tissue Repair, Synthetic Bone Graft

Tags: 510(k) Clearance, Regulatory