FDA Finalizes Classification of Bone Fixation Implant Device
The US Food and Drug Administration (FDA) recently finalized an order classifying in vivo cured intramedullary fixation rods as class II devices.The final order—effective as of 8 June—is aimed at reducing regulatory burden and ultimately improving patient access to the orthopaedic implanted devices. Each device consists of a balloon infused with liquid monomer intended for bone fixation in joint replacements.
FDA is issuing the classification in response to a December 2016 de novo classification request from IlluminOss Medical. “After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls,” FDA writes.
Built-in safety measures to prevent cross-contamination, validation of cleaning and disinfection instructions in the submitted performance data, as well as device insertion and removal demonstrated via performance testing are some the special controls that FDA is calling for to address the potential risks to health, such as balloon leakage or device migration.
Earlier this month, FDA proposed to down-classify certain medical image analyzers, including those that are computer-assisted/aided for mammography breast cancer, ultrasound breast lesions, among other use indications.
Medical Devices; Orthopedic Devices; Classification of the In Vivo Cured Intramedullary Fixation Rod