ADLER ORTHO SPA

Adler Ortho SPA specializes in orthopaedic devices primarily used in hip revision surgeries. Their portfolio includes uncoated femoral and tibial extension sleeves, reusable bone-resection orthopaedic reamers, trial acetabular and femoral prostheses, reusable joint prosthesis implantation kits, non-constrained polyethylene acetabular liners, and cross-linked polyethylene inserts. These devices are designed to assist surgeons during complex hip replacement procedures.

Adler Ortho SPA is based in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and distribution of its orthopaedic devices.

Adler Ortho SPA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify device details, such as manufacturer information and classification.

Adler Ortho SPA’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with.

The reusable instruments and components, such as bone-resection reamers, trial prostheses, and implantation kits, are designed to streamline hip revision surgeries by providing precision tools for preparing bone surfaces, testing prosthesis fit, and facilitating the implantation process. Reusability helps reduce surgical waste and may contribute to cost efficiency in operating rooms.