Current regulatory news

Next-generation multiport robotic system gains approval

The U.S. Food and Drug Administration (FDA) provided 510(k) clearance to Intuitive Surgical’s da Vinci 5, the company’s next-generation multiport robotic system. Da Vinci 5 builds on Intuitive’s da Vinci Xi’s highly functional design, and includes more than 150 enhancements, such as:

Improved accuracy and precision: Design and engineering enhancements, including new surgeon controllers and powerful vibration and tremor controls, make it the smoothest, most precise system Intuitive has developed to date.

Next-generation 3D display and image processing: Equipped with Intuitive’s highest quality and most natural 3D imaging system, it enables surgeons to see more and supports future generations of surgical endoscopes and vision software as those technologies evolve.

First-of-its-kind force-sensing technology: Force Feedback technology and optional instruments enable the system to measure, and surgeons to feel, subtle forces exerted on tissue during surgery. In preclinical trials, Force Feedback demonstrated up to 43% less force exerted on tissue, which may translate to less tissue trauma. Measuring this force adds a new data stream to surgical data science, bringing future analytical insights supported through artificial intelligence (AI).

Meaningful throughput and workflow enhancements: Da Vinci 5 is designed to help increase surgeon autonomy and streamline surgeon and care team workflow.

Expanded computing power and advanced data capabilities: Da Vinci 5 has more than 10,000x the computing power of Da Vinci Xi, enabling new system capabilities and advanced digital experiences, now and in the future.

Greater surgeon comfort: The system features a redesigned console capable of customizable positioning, allowing surgeons to find their best fit for surgical viewing and comfort, including the ability to sit completely upright.

https://www.intuitive.com

Surgically treating deformities, fractures

Orthofix Medical Inc. announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo Telescopic Nail. The Rodeo Telescopic Nail is a device intended to surgically treat deformities or fractures in patients suffering from osteogenesis imperfecta (OI). The nail implant serves to stabilize the patient’s limb while also elongating (or telescoping) to accommodate the natural growth of pediatric patients.

The Rodeo system is designed to address many of the biomechanical and procedural challenges associated with current OI telescopic rod systems. Specifically, its patented design provides the strength and reliable bone fixation required when implanting in the inherently fragile bone associated with OI patients. The implant procedure is streamlined, and the system’s instrumentation and sterile pack configurations optimize efficiency in the operating room, reducing procedural costs, O.R. time, and risks of contamination.

https://orthofix.com

Hip fracture treatment approval

OrthoXel announced 510(k) clearance for the Vertex Hip Fracture Nail (HFN). The foundation of the Vertex system rests on three key pillars: stability, versatility, and usability.

Stability: The primary aim of surgical intervention for hip fractures is stabilization. With the Vertex HFN, two proximal interdigitating screws produce enhanced screw fixation. The radially fluted nail stem ensures rotational and overall construct stability, particularly in the intertrochanteric and metaphyseal regions of the femur.

Versatility: The versatile design offers three proximal construct options to accommodate various fracture types, patient anatomies, and intra-operative requirements. Select between two interdigitating lag screw configurations, with inferior or superior screw placement or, alternatively, a solid lag screw is available for a conventional proximal construct.

Usability: Vertex enhances user experience with its design and integration into existing surgical workflows. Implants and instruments feature radiographic guides and cues for enhanced visualization during surgery.