Mixed-Reality System, HipInsight, Receives FDA Approval for Hip Surgery

The FDA has approved the first-of-its-kind mixed-reality system, HipInsight® 2.0, enhancing hip arthroplasty with 3D visualizations and patient-specific models. This technology projects surgical plans directly onto the patient, improving accuracy and enabling real-time comparisons during procedures. It revolutionizes traditional surgical methods and personalizes hip surgeries.

Surgical Planning Associates (SPA) announced that its groundbreaking mixed-reality guidance system, HipInsight® 2.0, has received FDA 510(k) clearance for hip arthroplasty. This innovative technology marks a milestone in surgical procedures, offering unprecedented precision and customization in hip surgeries. It allows surgeons to maintain their focus on the patient without the frequent need to consult external monitors or imagery.

Dr. Matt Miller of Stanford Orthopedic Surgery, emphasizes the system's ability to tailor surgical plans to individual patients. "Every patient's anatomy and hip arthritis is unique," Dr. Miller notes. "HipInsight allows a customized 3D model that helps a surgeon plan for and execute a more perfect reconstruction for each individual patient."

A Leap into Mixed-Reality in Medicine

The HipInsight® 2.0 is the only patient-specific mixed-reality system currently approved for both primary and complex revision hip arthroplasty. This technology provides surgeons with what can be described as 'x-ray vision,' allowing them to view detailed, three-dimensional information directly in and around the patient’s hip joint during surgery.

Traditional hip surgery often relies on preoperative two-dimensional X-ray planning combined with intraoperative assessments. The HipInsight® system enhances this process by projecting three-dimensional surgical data onto the lenses of mixed-reality eyeglasses."

Advancing Surgical Precision

One of the most significant innovations of the HipInsight® system is its newly patented method of overlaying digital content directly onto the patient’s surgical site. This capability extends the workflow, making it more seamless and adaptable to various surgical techniques.

Dr. Kevin Park from Houston Methodist highlights the enhancements over the original system, stating, “HipInsight System 2.0 advances the already amazing capabilities of the original system. The new functionality supports the surgeon for even the most complex primary and revision surgery challenges that we encounter.”

Moreover, the system introduces the concept of "future X-rays," which are pre-generated images showing the desired outcome of the surgery. These can be projected over intraoperative X-rays, offering a live comparison that can guide surgeons during the procedure. This feature is complemented by new tools for rapidly assessing changes in leg length and hip width post-surgery.

A Synergistic Collaboration

SPA’s partnership with ZimmerBiomet, encapsulated in an exclusive, multi-year co-marketing agreement, has been pivotal in developing and promoting the HipInsight System. Steve Vankoski, Vice President of Marketing at ZimmerBiomet, remarks on the collaboration: "Our companies have been able to work synergistically through our exclusive collaboration to successfully support clinical use of this fast evolving, transformative technology."

This approval is crucial as it validates the safety and efficacy of using advanced mixed-reality technology in hip arthroplasty. It offers surgeons enhanced visualization and precision, ultimately leading to improved patient outcomes and potentially setting a new standard in surgical practices globally.

About Author: Mithat Can Turan

I am a software developer and a 4th-year Computer Engineering student at the Turkish-German University. I have worked on numerous software projects, especially those related to healthcare. My primary interests lie in digital health and AI applications within healthcare projects. I closely follow the latest developments in AI and digital health.