2026 ISASS Spine Bone Graft Policy Update: Class III Technologies and Contemporary Evidence Maturation.

BACKGROUND

The 2018 International Society for the Advancement of Spine Surgery (ISASS) bone graft policy established the society's comprehensive framework for bone graft substitutes in spinal surgery. Additionally, a subsequent independent 2019 analysis by Marx and Lorio examined the regulatory and evidentiary distinctions applicable to class III spinal grafts. Since those publications, substantive regulatory, evidentiary, and technological developments have emerged that warrant a focused ISASS policy update.

METHODS

A focused regulatory and clinical evidence landscape review was conducted to answer the question, "What has materially changed since the previous ISASS review?" The review aimed to identify substantive regulatory, evidentiary, and technological developments warranting policy reassessment, not to constitute a comprehensive systematic re-review.

RESULTS

Two principal areas of class III/premarket approval maturation were identified: continued regulatory and evidentiary maturation of rhBMP-2/INFUSE and maturation and expansion of P-15 peptide technology through distinct i-FACTOR cervical and PearlMatrix lumbar premarket approval pathways. AUGMENT and MagnetOs serve as complementary regulatory and evidentiary boundary examples rather than additional class III spinal maturation pathways.

CONCLUSIONS

Regulatory pathway, biological mechanism, Food and Drug Administration indication, clinical evidence, coding, coverage, and reimbursement are related but distinct dimensions of spinal bone graft assessment and should not substitute for one another. Graft selection ultimately remains within the treating surgeon's purview (Figure).