DEPUY INTERNATIONAL LTD

Depuy International Ltd specializes in reusable orthopaedic instruments and trial prostheses primarily used in hip and knee replacement surgeries. Their devices include positioning instruments for prosthesis implantation, femoral stem and acetabulum trials, broaches, knee femur and tibia prosthesis trials, and surgical implant templates. These tools help surgeons achieve precise implant placement during procedures.

Depuy International Ltd is based in the United States. The company’s headquarters and operations are located within the country, though it may have global distribution or subsidiary networks for its devices.

Depuy International Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.

Depuy International Ltd’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s purpose, potential risks, and intended use in orthopaedic procedures.

The trial prostheses produced by Depuy International Ltd, such as femoral stem trials, acetabulum trials, and knee femur/tibia trials, are used during surgery to test fit, alignment, and sizing before permanent implants are placed. This step ensures the final prosthesis will be correctly positioned, improving surgical outcomes and reducing complications.