Background: The clearance of medical devices by the US Food and Drug Administration (FDA) has remained largely unchanged since 1976, when the Medical Device Amendments Act established a system classifying devices into 3 categories based on safety risk to the consumer. The system allows for the clearance of many orthopedics devices through the 510(k) premarket pathway, which is based on "predicate ancestors," previously cleared devices that are "substantially equivalent." Purpose: We sought to trace the predicate ancestors of modern total knee arthroplasty (TKA) devices, specifically those recently cleared for marketing by the 510(k) pathway that claim substantial equivalence to prior devices, despite potential differences in material science and design. In addition, we aimed to document which TKA devices cleared by the 510(k) pathway have substantial equivalence to devices that have since been recalled by the FDA. Methods: To create a comprehensive list of TKA devices, we used FDA Classification Process Codes corresponding to knee arthroplasty to search the FDA's databases from May 28, 1976, the start of the 510(k) process, to May 1, 2021. Of 1309 resulting devices, 89 were excluded as not related to arthroplasty. For each of the remaining devices, we analyzed the descendant devices that claimed substantial equivalence, either directly or indirectly. We used data of recalled designs to determine both the absolute number of recalled devices and the number of currently cleared devices that presented substantial equivalence claims upon predicates that have since been recalled. Results: Of 1220 knee devices cleared or approved, 6 (0.5%) were approved through the premarket approval application (PMA) process, and 1214 (99.5%) were cleared through the 510(k) pathway. Of the 1214 cleared devices, 217 (17.9%) have been recalled and 204 (16.8%) have ties to at least 1 recalled predicate device linked through generational claims of substantial equivalence. We found 90 devices (7.4%) linked directly to a recalled predicate device. Conclusions: Most knee arthroplasty devices are cleared for marketing through reliance on a complex web of equivalency to previously cleared predicates. We found that many TKA devices thus connected were cleared decades apart, with multiple iterations of design and material modifications. Many currently marketed TKA devices have claimed equivalency to predicates that have been recalled. Our findings suggest the need for novel regulatory strategies that might further patient safety while balancing the unwanted effects of regulatory burden.
Despite growing evidence supporting the evaluation, classification, and treatment of acetabular bone loss in revision hip replacement, advancements have not been systematically incorporated into a single document, and therefore, a comprehensive review of the treatment of severe acetabular bone loss is needed. The Stavros Niarchos Foundation Complex Joint Reconstruction Center at Hospital for Special Surgery held an Acetabular Bone Loss Symposium on June 21, 2019, to answer the following questions: What are the trends, emerging technologies, and areas of future research related to the evaluation and management of acetabular bone loss in revision hip replacement? What constitutes the optimal workup and management strategies for acetabular bone loss? The 36 international experts convened were divided into groups, each assigned to discuss 1 of 4 topics: (1) preoperative planning and postoperative assessment; (2) implant selection, management of osteolysis, and management of massive bone loss; (3) the treatment challenges of pelvic discontinuity, periprosthetic joint infection, instability, and poor bone biology; and (4) the principles of reconstruction and classification of acetabular bone loss. Each group came to consensus, when possible, based on an extensive literature review. This document provides an overview of these 4 areas, the consensus each group arrived at, and directions for future research.
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