IMPLANTS INTERNATIONAL LTD

Implants International Ltd specializes in orthopedic implants for hip and knee replacements. Their product range includes constrained polyethylene acetabular liners, metallic and ceramic femoral head prostheses, acetabular shells, tibial inserts, modular femoral stems, uncoated metallic knee tibia prostheses, and coated hip femur prostheses. These devices are designed for both primary and revision surgeries, addressing various joint replacement needs.

The company is headquartered in the United States. This location allows them to comply with FDA regulations and participate in domestic and international markets for orthopedic implants.

Implants International Ltd’s devices are listed in the FDA’s 510(k) premarket notification system and the Unique Device Identification (UDI) database. These registries ensure traceability and compliance tracking for Class II orthopedic implants.

The company’s devices fall under Class II classification according to FDA regulations. This classification applies to implants that pose moderate risk and require special controls to ensure safety and effectiveness, such as orthopedic joint replacements.