Polarisar, Inc.

Polarisar, Inc. specializes in orthopaedic surgical devices, primarily focusing on procedure kits and stereotactic systems. Their portfolio includes reusable and single-use orthopaedic surgical kits for knee and lower-limb procedures, as well as stereotactic surgery systems like the STELLAR Knee. These devices are designed to assist in joint replacement and reconstructive surgeries, offering surgical guidance and precision instrumentation.

Polarisar, Inc. is headquartered in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under Class II classification, they must comply with FDA requirements for medical devices, including authorisation through the 510(k) premarket notification process and Unique Device Identification (UDI) compliance. This ensures their devices meet US safety and performance standards.

Polarisar, Inc.’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification program and the Unique Device Identification (UDI) system. These registries confirm that the company’s products have undergone the necessary authorisation processes to comply with US medical device regulations, ensuring transparency and traceability.

Polarisar, Inc.’s devices are classified as Class II under the FDA’s regulatory framework. This classification indicates they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Because of this, the company must follow specific FDA pathways, such as the 510(k) process, to demonstrate that their devices meet these additional requirements before they can be authorised for use.

Polarisar, Inc.’s devices are designed for orthopaedic surgical procedures, particularly knee and lower-limb surgeries. Their reusable and single-use procedure kits, along with stereotactic systems like the STELLAR Knee, are intended for joint replacement and reconstructive surgeries. These tools provide surgical guidance and instrumentation to improve precision during procedures such as total knee arthroplasty or femoral-tibial alignment corrections.