FLOW FLEXTEND Wand (72290039)

The FLOW FLEXTEND Wand is a single-use, bipolar radiofrequency electrosurgical device designed for resection, ablation, and coagulation of soft tissues and hemostasis in arthroscopic and orthopedic procedures across multiple joints (hip, knee, shoulder, wrist, ankle, elbow). It connects to existing WEREWOLF and INTELLIO SHIFT controller systems and can be activated via integrated finger switches or foot pedal.

The subject device has a longer overall length (14.5 inches vs. 11.5 inches predicate), a 45° electrode orientation (vs. 90° predicate), and an adjustable shaft angle ranging from -10° to +65° with a mechanical hold feature (vs. fixed shaft predicate). Both are bipolar, single-suction-port, single active-electrode devices with identical distal tip components, sterilization method, and compatible controller systems.

ISO 10993-1 (biocompatibility evaluation), IEC 60601-1 and IEC 60601-2-2 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), AAMI TIR28:2016/(R)2024 (sterilization validation), and FDA guidance on device software functions.

The FLOW FLEXTEND Wand is substantially equivalent to the predicate FLOW 90 Wand because they share identical intended use, principle of operation (bipolar RF coblation), core design elements, materials, and performance. Ex vivo testing demonstrated equivalent thermal effect depth, width, and ablation depth across tissue models. The geometric differences (length, electrode angle, adjustable tip) provide ergonomic and clinical access benefits without altering fundamental function or safety.