"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 Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data conducted to support a Premarket Approval (PMA).
- 510k - Premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.
- HCTP - Human cells, tissues, and cellular and tissue-based products that are regulated by the Center for Devices and Radiological Health (CDRH) as medical devices and those that are regulated by the Center for Biologics Evaluation and Research (CBER).
2) Mechanism of action (MOA)
The mechanical or biological process through which a product produces its effect in the human body. Examples used include:
- Osteogenesis - The cells needed for the development and formation of bone.
- Osteoinduction - The signal needed to induce the formation of bone.
- Osteoconduction - The matrix needed to support the growth of bone.
3) Supportive clinical evidence
The safety and performance information used to support the marketing of the product.
4) Product types
A group of similar products with common characteristics.
Study Summary:
When considering available bone grafting products to induce new bone, the most critical requirements for success are adequate blood supply and at least two of the bone graft mechanisms of action (MOA) identified above. Bone grafting products can be put into six of the following product types differentiated by FDA Approval Pathway, MOA and Supportive Clinical Evidence:
| Bone Grafting Product | Approval Pathway | Mechanism of Action (MOA) | Supportive Clinical Evidence |
| Nonstructural allografts | HCTP | Osteoconduction (matrix) | No premarket data review by FDA |
| Demineralized bone grafts | 510k | Osteoconduction (matrix), "theoretical" osteoinductive (signal) | Animal study data review by FDA |
| Cellular-based allografts | HCTP | Osteoconduction (matrix), "theoretical" osteoinductive (signal) | No premarket data review by FDA |
| Synthetic bone grafts | 510k | Osteoconduction (matrix) | Animal study data review by FDA |
| Autologous cellular grafts | 510k | Osteogenesis (cells) | In-vitro data review by FDA |
| Class III drug device combination products | IDE/PMA | Osteoconduction (matrix), osteoinductive (signal) | Level 1 IDE human study review by FDA |
Over the past 3 decades, there has been an increased interest in bone grafting materials and they have become a vital part of most spinal procedures. With the growing global bone grafting market valued at $2.4B USD in 2016, we should expect more companies to enter the market bringing even more confusion in the future.
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