Bone grafting sits at the intersection of biology, engineering, clinical judgement and regulation, and no single reference has covered all four. Safety and Effectiveness Profiles of Bone Grafts and Bone Graft Substitutes closes that gap.
Written for orthopedic, spine, dental, maxillofacial and podiatric surgeons, and for the device-safety, regulatory, biomaterials and value-analysis professionals who support them, this 34-chapter reference profiles every major graft class in use today: autograft, structural and particulate allograft, demineralized bone matrix, calcium phosphate and bioactive ceramics, bioactive glass, collagen composites, synthetic peptides, cellular bone matrices, platelet concentrates, and the recombinant growth factors rhBMP-2 and rhPDGF-BB.
Every profile follows the same structure: composition and mechanism, the biological properties actually supplied (osteogenic, osteoinductive, osteoconductive), handling characteristics, the clinical evidence and its maturity, the documented safety signals, the regulatory pathway that governs it, and an explicit statement of what the evidence does not support.
What sets this reference apart:
- A practitioner decision algorithm that opens with three stop conditions (infection, mechanical inadequacy, compromised perfusion) and terminates in a required property profile rather than a named product.
- A landscape plate mapping 23 graft classes by biology supplied, structural role, evidence maturity, scope of evidence and principal safety concern, with no composite score and no ranking.
- Dedicated chapters on device-safety methodology: signal detection, causality assessment, post-market surveillance and registry evidence, drawn from the author's years of safety leadership across a global spinal portfolio and the rhBMP-2 clinical programme.
- Separate United States (FDA) and European Union (MDR) regulatory chapters covering 510(k), PMA, HCT/P and tissue-bank oversight, and CE marking.
- Four appendices: a controlled-vocabulary glossary, a master comparison matrix, a safety signal register and a fully referenced source library.
- An interactive companion selection tool that accompanies the book online.
Product-neutral throughout, referenced in Vancouver style, and written so that a surgical trainee, a regulatory reviewer and a hospital value-analysis committee can work from the same evidence base.
