Enhatch has received the US Food and Drug Administration (FDA) 510(k) clearance for its artificial intelligence (AI)-based specific instrumentation system, designed for total knee arthroplasty (TKA).

The system’s AI-powered approach includes the generation of anatomic models and treatment planning.

According to Enhatch, the AI algorithms of the system are capable of converting CT or X-ray images of patients into intricate 3D anatomic models that may be used in treatment plans. This process results in a more effective way to create highly customised surgical guidance, the American firm said.

Enhatch president and CTO 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 modeling of individual anatomies and planning treatments, we are setting new benchmarks within the industry.”

Enhatch stated that using X-ray based systems for preoperative planning helps in surgical preparation by offering lowered radiation exposure in comparison to conventional full knee CT scans.

This method reduces the amount of radiation that the patient is exposed to while helping the creation of precise and customised surgical plans by using accurate anatomic models.

Additionally, the integration of this technology enables a streamlined process for both patients and healthcare providers with a focus on safety, accuracy, and affordability.

3D Systems, Enhatch’s partner, is manufacturing, packaging, and shipping the patient specific instrumentation system to deliver the instrument kits to the point-of-care.

Both firms entered into a partnership in March 2022 to scale the design and delivery of patient-specific medical devices.

Enhatch uses its advanced software solutions to deliver personalised implants and instruments.