Enhatch has secured US Food and Drug Administration (FDA) 510(k) clearance for its patient-specific AI-driven instrumentation system for total knee arthroplasty.

The system utilises AI to transform patient X-rays or CT images into detailed 3D anatomic models.

These models are integral for the development of comprehensive treatment plans and the creation of customised surgical guides, streamlining the surgical process.

Enhatch president and chief technology officer Michael Phipps said: “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 modelling of individual anatomies and planning treatments, we are setting new benchmarks within the industry.”

The new technology is said to be a leap forward in preoperative planning by using X-ray based systems, which offer the advantage of reduced radiation exposure when compared with traditional full-knee CT scans.

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The reduction in radiation is not only beneficial for patient safety but also enhances the precision of anatomic models.

X-rays are more readily available and commonly reimbursed within the US healthcare system, making this AI-driven method a more operationally efficient and cost-effective option for total knee arthroplasty.

The approach prioritises patient safety, accuracy and affordability in surgical preparation.

Enhatch senior project R&D manager Scott Mozeleski said: “We are excited to launch this new end-to-end patient-specific system designed to seamlessly integrate into surgical practices. 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.”

Enhatch has partnered with 3D Systems for manufacturing, packing and delivering patient-specific instrumentation to healthcare providers.