Confused by all of these biologic bone grafting products? (Relatable Healthcare)
"I’m confused about all of these biologic bone grafting products."
If you are a healthcare provider or administrator dealing with spine surgery, you have probably heard this statement before. You might have even said it yourself. Trying to understand the claims and capabilities of bone grafting products can lead to even more confusion.
The International Journal of Spine Surgery (IJSS) recently published a study that provided a very insightful introduction and history of bone grafting products comparing and contrasting US regulatory pathways, mechanism of action, supportive clinical evidence requirements, and descriptive text on how the product types differ.
Let’s first understand the terminology used in the publication when comparing and contrasting bone grafting products below:
1) US regulatory pathways
The process to ensure the protection of public health by reviewing the safety, efficacy, and security of these products implanted into the body. The most rigorous, costly and time consuming approval by far is an IDE/PMA.
Examples used include:
IDE/PMA - A FDA approved Investigational De...
