Hans Biomed Corporation

Hans Biomed Corporation specializes in human-derived bone matrix implants, including products like putty formulations and allograft-based materials. Their portfolio also covers bioabsorbable polyester sutures and monofilament lift threads, which are designed for soft tissue support. These devices are primarily used in orthopedic and dental procedures for bone regeneration, grafting, and surgical fixation.

Hans Biomed Corporation is based in the United States. Their devices are authorised for use in the US, where they are regulated under FDA guidelines. The company’s products are classified as Class II, indicating they pose moderate risk and require specific regulatory pathways like 510(k) clearance and UDI registration.

Hans Biomed Corporation’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with US regulatory requirements for Class II medical devices, which include bone matrix implants and bioabsorbable sutures.

Hans Biomed Corporation’s devices are classified as Class II under FDA regulations. This classification applies to products that generally pose moderate risk to patients and require special controls beyond general controls to ensure safety and effectiveness. Examples include bone matrix implants and bioabsorbable sutures, which undergo 510(k) clearance to demonstrate their compliance with regulatory standards.

The FDA classifies Hans Biomed’s devices as Class II because they are intended for procedures involving bone regeneration, grafting, or soft tissue support, where moderate risks—such as improper placement or adverse tissue reactions—could occur. Class II classification requires manufacturers to submit a 510(k) premarket submission to demonstrate that their devices are substantially equivalent to legally marketed predicates, ensuring they meet performance and safety standards without the higher scrutiny of Class III devices.