Augma Biomaterials, Ltd.

Augma Biomaterials, Ltd. specializes in synthetic bone graft materials. These devices are primarily used in orthopedic and maxillofacial surgeries to aid bone regeneration and integration, serving as alternatives to traditional autologous bone grafts. Examples include Bond Apatite, 3D Bond+, and BOND BONE.

The company is headquartered in the United States. This location influences its regulatory compliance framework, particularly under U.S. authorities like the FDA.

Augma Biomaterials’ devices fall under FDA Class II classification. This classification is typically assigned to devices with moderate risk, requiring special controls to ensure safety and effectiveness beyond general controls. Class II devices often require pre-market submissions like the 510(k) pathway to demonstrate substantial equivalence to a predicate device.

Augma Biomaterials’ devices are listed in the FDA’s 510(k) registry and the FDA’s Unique Device Identifier (UDI) system. The 510(k) pathway is used to demonstrate that a new device is at least as safe and effective as an existing predicate device, while the UDI system ensures standardized identification for tracking and traceability.