AJU PHARM. CO., LTD.

AJU Pharm. Co., Ltd. specializes in orthopaedic surgical devices, including tendon and ligament bone anchors (both bioabsorbable and non-bioabsorbable), bioabsorbable orthopaedic bone screws, and reusable tools like surgical drill guides and bone taps. They also produce single-use items such as arthroscopic access cannulas and fluted surgical drill bits, designed for procedures like ligament repair or joint reconstruction. These devices are engineered to support fixation, access, and precision drilling in orthopaedic surgery.

AJU Pharm. Co., Ltd. is based in the United States, which means its devices must comply with FDA regulations. Since the company’s products fall under FDA classifications (Class I and Class II), they are subject to domestic submission requirements like the 510(k) pathway for premarket notifications and the Unique Device Identifier (UDI) system for traceability. Compliance ensures these devices meet U.S. safety and performance standards before use.

AJU Pharm. Co., Ltd.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) pathway is used for Class II devices to demonstrate substantial equivalence to a predicate device, while the UDI system ensures standardized identification for tracking and traceability. These registries help healthcare providers and regulators verify device compliance and history, supporting safe clinical use.

AJU Pharm. Co., Ltd.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and require general controls, while Class II devices—like certain bone anchors or arthroscopic tools—may need special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) submissions for Class II, ensuring appropriate oversight based on device risk.