JAAOS - 2026-07-15 - Journal Article; Review
The Evidence Basis and Regulatory Framework for Biologic Augmentation of Foot and Ankle Surgeries.
Haupt ET, Shi GG, Shapiro SA
Topics
Key Takeaway
BMAC achieves fusion rates comparable to autograft in select foot and ankle applications, yet neither BMAC nor PRP carries specific FDA approval as a therapeutic, operating instead through the Same Surgical Procedure Exemption or device-level regulation.
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Summary
This narrative review examines the clinical evidence and FDA regulatory framework governing orthobiologic use in foot and ankle surgery. BMAC demonstrates fusion rates comparable to iliac crest autograft in some arthrodesis studies, while PRP evidence remains conflicting due to absent preparation standardization. Regulatory analysis reveals that most orthobiologics reach clinical use via the Same Surgical Procedure Exemption or device clearance rather than premarket approval, creating a therapeutic approval gap that mandates explicit informed consent.
Key Limitation
As a narrative review without a registered protocol or systematic search, the conclusions on comparative fusion rates and PRP efficacy cannot be quantitatively verified and may reflect publication bias toward positive orthobiologic outcomes.
Original Abstract
Biologic augmentation, using substances like bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP), shows promise for improving outcomes in foot and ankle surgery, particularly in high-risk patients. Historically, autologous bone graft is the benchmark due to its trifecta of osteogenic, osteoinductive, and osteoconductive properties, despite its associated donor site morbidity. Current evidence supporting orthobiologics remains fragmented and inconclusive, with a lack of high-level randomized controlled trials (RCTs). BMAC shows fusion rates comparable to autograft in some foot and ankle applications, but PRP evidence is often conflicting due to a lack of preparation standardization. The regulatory environment is complex. The Food and Drug Administration (FDA) oversees human cells and tissues (HCT/Ps) through a tiered system: high-risk §351 products (eg, cultured stem cells) require rigorous premarket approval, whereas §361 products (eg, allograft bone) have minimal oversight. BMAC and PRP often bypass this through the Same Surgical Procedure Exemption or are regulated through their processing devices, meaning the biologics themselves are not FDA-approved therapeutics. This regulatory gap and direct-to-consumer marketing necessitate meticulous informed consent, transparently discussing the lack of specific FDA approval, limited evidence, and high out-of-pocket costs. Future success depends on standardized, prospective RCTs and a collaborative "middle-ground pathway" for regulatory approval.