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

Authors

William F Lavelle, Mitchell S Fourman, Roy Y Miloh, Divya Jain, Alexander R Vaccaro, Oscar L Alves, Addisu Mesfin, Umesh S Metkar, Ava-Kathleen D Rybicki, Morgan P Lorio

Published in

International journal of spine surgery. Oct 13, 2026. Epub Oct 13, 2026.

Abstract

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.
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.
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.
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).

PMID:
42869665
Bibliographic data and abstract were imported from PubMed on 14 Oct 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.