(1) Background: Minimally invasive sacroiliac joint (SIJ) fusion is the preferred surgical intervention to treat chronically severe pain associated with SIJ degeneration and dysfunction. (2) Methods: This paper details the ten-step surgical procedure associated with the postero-inferior approach using the PsiF™ DNA Sacroiliac Joint Fusion System. (3) Results: The posterior surgical approach with an inferior operative trajectory (postero-inferior) utilizes easily identifiable landmarks to provide the safest, most direct access to the articular joint space for transfixing device placement.
View Article and Find Full Text PDFThe primary objective of this review is to evaluate whether the degree of processing and the clinical utility of commercially available mineralized bone allografts for spine surgery meet the 2020 US Food and Drug Administration's (FDA) guideline definitions for and , respectively. We also assessed the consistency of performance of these products by examining the comparative postoperative radiographic fusion rates following spine surgery. Based on the FDA's criteria for determining whether a structural allograft averts regulatory oversight and classification as a drug/device/biologic, mineralized bone allografts were judged to meet the Agency's definitional descriptions for and when complying with the American Association of Tissue Banks' (AATB) accredited guidelines for bone allograft harvesting, processing, storing and transplanting.
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