Handheld Surgical Polymer Injection System

A global leader in orthopedic and surgical solutions partnered with PSI to design and develop a cutting-edge Class III handheld medical device used in complex fracture repair procedures. Intended for use in operating rooms, the device enables orthopedic surgeons to rapidly reassemble severely shattered bones using a biodegradable polymer that is heated and applied directly to fracture sites. The system provides a revolutionary approach to internal fixation by allowing clinicians to “stitch” bone fragments together in minutes, enhancing surgical outcomes and reducing procedure times.

PSI was responsible for the complete software design and development of the device’s real-time embedded system, which is powered by a microprocessor housed within the handheld unit. The firmware precisely controls the heating process to reach a specific temperature setpoint required to activate the polymer compound. Sophisticated control logic and feedback mechanisms ensure that optimal heat and bonding conditions are achieved and maintained throughout the procedure.

Developed in accordance with FDA 21 CFR Part 11 and Part 820 requirements, ISO 900 standards, and object-oriented programming principles, the software system was engineered to meet the rigorous demands of safety-critical, surgical-grade medical devices. Unique firmware features were implemented to manage real-time temperature control, form bond points, and deliver the responsive performance needed in high-pressure surgical environments.

By combining deep experience in medical-grade embedded systems with strict regulatory compliance, PSI delivered a robust, reliable solution that supported the client’s mission to innovate in orthopedic care. The handheld polymer heating device has become a vital tool in advanced fracture treatment, empowering clinicians with greater speed, control, and precision in the operating room.