Orthosoft Inc

Orthosoft Inc specializes in orthopaedic devices primarily used during joint prosthesis implantation. Their portfolio includes single-use and reusable positioning instruments for shoulder, hip, and knee surgeries, such as osteotomy guides and joint prosthesis implantation kits. They also develop robotic surgical navigation systems—like the ROSA® platform—and associated software for radiology image processing and surgical planning. Additionally, they produce reusable sterilization containers for their orthopaedic instruments.

Orthosoft Inc is headquartered in the United States. Their devices are designed and manufactured there, and they are intended for use within the U.S. regulatory framework. Availability outside the U.S. would depend on local regulatory approvals, which are not addressed in the company’s publicly available information.

Orthosoft Inc’s devices are listed under the U.S. Food and Drug Administration’s (FDA) 510(k) premarket notification program and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with FDA requirements for medical devices in the U.S. The 510(k) program assesses substantial equivalence to predicate devices, while the UDI system standardizes device identification.

Orthosoft Inc’s devices are primarily classified as Class I or Class II under FDA regulations. 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 intended use, potential risks, and the body area involved (e.g., orthopaedic implants carry higher risk than low-risk positioning instruments).

Orthosoft Inc’s robotic surgical navigation systems, such as the ROSA® platform, integrate advanced software and hardware to assist surgeons in precise joint prosthesis implantation. Unlike their reusable positioning instruments or osteotomy guides—which are physical tools used during surgery—the robotic systems combine real-time imaging (e.g., DICOM-based radiology data) with robotic guidance to enhance accuracy and reduce human error. This makes them distinct as high-tech solutions requiring both hardware and software validation.