Enhatch has obtained U.S. FDA 510(k) clearance for its patient-specific instrumentation system for total knee arthroplasty. This system uses AI for anatomic modeling and treatment planning, converting patient X-rays or CT scans into 3D models to create personalized surgical guides. These instrument kits are manufactured and distributed by Enhatch’s partner, 3D Systems, for efficient delivery to the point-of-care.

“The recent FDA clearance represents a major company milestone in advancing surgical precision and elevating the standard of patient care,” says Michael Phipps, president and CTO of Enhatch. “Our Intelligent Surgery Knee software plays a pivotal role in streamlining preoperative planning and crafting patient-specific guides with enhanced efficiency. Leveraging cutting-edge AI technology for accurate modeling of individual anatomies and planning treatments, we are setting new benchmarks within the industry.”

Using X-ray-based systems for preoperative planning reduces radiation exposure compared to full knee CT scans. This approach enhances safety and precision in creating anatomical models for tailored surgical strategies. X-rays are widely available and reimbursed in the U.S. healthcare system, making it an efficient and cost-effective choice for both patients and healthcare providers.

“Surgeons can effortlessly submit X-ray or CT images, along with treatment details and preferences. Our advanced AI algorithms then go to work to generate precise anatomic models, information for preoperative plans, and surgical guide designs. Planners assess the generated outputs and actively collaborate with surgeons to ensure thorough review and approval of the preoperative plans,” says Scott Mozeleski, senior project R&D manager of Enhatch.

“By harnessing the power of AI-driven technologies, we aim to optimize surgical workflows for patient-specific surgeries. This commitment aligns with our objective in providing a heightened level of professionalism to patient care,” Mozeleski adds.