Copy to clipboard 
Enhatch announced FDA 510(k) clearance of a patient-specific instrumentation system for Total Knee Arthroplasty. The system supports TKA with its AI-driven approach, encompassing both anatomic model generation and treatment planning. The system’s AI algorithms can convert either patient x-rays or CT images into 3D anatomic models to be used in treatment plans, culminating in the efficient creation of personalized surgical guides.
The use of x-ray-based systems for preoperative planning marks a significant advancement in surgical preparation, offering reduced radiation exposure compared to traditional full knee CT scans. This approach lessens the patient’s exposure to radiation and serves as a cornerstone in generating accurate anatomic models, allowing for more precise and tailored surgical strategies. X-rays are more accessible and widely reimbursed in the U.S. healthcare system, making this method an operationally efficient and cost-effective solution. By integrating this technology, both patients and healthcare providers benefit from a streamlined process that emphasizes safety, accuracy and affordability.
The Patient Specific Instrumentation is manufactured, packaged and shipped by 3D Systems, Enhatch’s manufacturing partner.
“The recent FDA clearance represents a major company milestone in advancing surgical precision and elevating the standard of patient care. 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,” commented Michael Phipps, President and CTO of Enhatch, Inc.
Source: Enhatch Inc.
