In the mid- 2000s, annual sales of BMP-2 rose to approach $900 million per year, but, in response to new data and the medico-legal concerns, revenues declined to less than $450 million annually in 2017. Further, in 2001, the first Class III medical device grafting material was approved by the FDA, bone morphogenetic protein (BMP)-2. In 2006, the regulatory pathway significantly changed in the United States regarding DBMs, with the Food and Drug Administration (FDA) reclassifying versions of DBMs with a non- tissue carrier to require 510(k) clearance, while leaving pure DBM versions exempt as human tissue products. Whereas DBMs were initially classified as tissue product and not a medical device, synthetics were classified as medical devices subject to the 510(k) pathway. In the 1990s, demineralized bone matrix (DBM) and synthetic bone grafts became widely available. When evaluating the complex landscape of grafting materials, it is difficult to compare the options as the regulatory pathways, mechanisms of action, and supportive clinical evidence of the materials vary widely.
The combination of these properties can either come from materials introduced to the site or those recruited from the host. The matrix is the scaffolding that permits cell infiltration and in-growth of new host bone that is referred to as osteoconduction. The signal, or osteoinduction, is orchestrated by bioactive molecules, primarily low-molecular-weight members of the transforming-growth-factor–b family that actively recruit mesenchymal cells, and stimulate them to differentiate into bone-forming cells for osseous repair. These are dedicated cells in the area of the graft, such as osteoblasts or stem cells, that enter the osteoblastic lineage and ultimately form new bone. Cells refers to the process of osteogenesis that is defined as cellular formation of new bone. When considering potential graft materials, assuming an adequate blood supply, it is important to note that a successful graft needs to have at least 2 of the following: cells, signal, and/or matrix. Unlike other areas of orthopedics, spinal surgery often requires grafting procedures to induce de novo bone in an area stabilized by metal devices. Over the past 3 decades, there has been an increased interest in bone grafting materials as these materials have become a vital part of most spinal procedures. LORIO, MD, FACS 2ġ Hospital for Special Surgery, New York, New York, 2Hughston Clinic Orthopaedics, Nashville, Tennessee ISASS Recommendations and Coverage Criteria for Bone Graft Substitutes used in Spinal SurgeryĬELESTE ABJORNSON, PHD, 1 ANTONIO BRECEVICH, MD, 1 TUCKER CALLANAN, MS, 1 CHRISTINA DOWE, BS, 1 FRANK P.
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