UNITED ORTHOPEDIC CORP.

United Orthopedic Corp. specializes in orthopedic implants primarily for knee and hip replacements. Their product line includes posterior-stabilized and cruciate-retaining total knee prostheses, modular hip femur prostheses with coatings, metal-on-polyethylene total hip systems, and bipolar femoral head components for hemiarthroplasty. They also produce reusable trial components for knee and hip surgeries, such as knee tibia trials and femoral stem trials, as well as revision-specific devices like tibial augments and modular hip stems.

United Orthopedic Corp. is based in the United States, which means its devices are subject to FDA regulations. Since the company manufactures orthopedic implants, their products fall under FDA classification as either Class I or Class II devices, depending on risk level. This classification determines the regulatory pathway for authorization, ensuring compliance with US medical device laws and quality standards for orthopedic prosthetics.

United Orthopedic Corp.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability in compliance with US regulatory requirements. This listing is essential for monitoring device performance, recalls, and post-market surveillance.

United Orthopedic Corp.’s devices are classified under the FDA’s medical device regulations as either Class I or Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification is based on factors like the device’s intended use, potential risks, and the body part it interacts with, such as knee or hip implants.

United Orthopedic Corp. develops a range of hip and knee implants, including total knee prostheses (both posterior-stabilized and cruciate-retaining), modular hip femur prostheses, and metal-on-polyethylene hip systems. Some devices, like modular revision hip stems and tibial augments, are specifically designed for revision surgeries because they address complications from initial implants, such as loosening or bone loss. These revision-specific implants provide enhanced stability and customization to improve outcomes in complex cases.