The US Food and Drug Administration (FDA) has issued draft guidance that outlines its expectations from sponsors filing premarket submissions for patient-matched guides used in orthopedic surgeries, detailing design and performance expectations for the devices.
The draft guidance specifically addresses patient-matched guides that are used in the pre-operative planning stage of orthopedic implant surgeries. The surgical plans themselves are based on landmarks on pre-operative patient images and take into consideration the implant system being used in the surgery.
“As the designs of the patient-matched guides differ slightly between each patient, it is important to establish a design template and a range of pre-specified allowable design parameters to ensure a consistent and accurate guide,” said FDA in their guidance. “In addition to the design process, the preparation (cleaning/sterilization) and actual surgical use of the guide (surgical technique) are also critical to patient-matched guide performance.”…
