ORCA Database Methodology: Sacroiliac, Ankle, and Hip Implants
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Contributing OfficeCenter for Devices and Radiological Health
Abstract
Review of premarket notification (510(k)) submissions for orthopedic implants often involves the comparison of design characteristics and mechanical testing results between the newly proposed device and previously cleared “predicate” devices. To streamline the review of future 510(k)s, design information and mechanical testing data were entered into the Orthopedic Rapid Comparative Analysis (ORCA) database for sacroiliac joint implants, total ankle replacements, and total hip replacements. Data was extracted from previously reviewed 510(k) submissions and Q-submissions, including device materials, dimensional ranges, mechanical testing methods and results, and prevalence of other evaluations such as clinical trials or cadaver studies. Once the data was aggregated and filtered to eliminate invalid data points, analysis allowed for the minimum and maximum values within each design or mechanical testing parameter of interest to be identified and recorded. For sacroiliac joint devices, the five most common mechanical tests were Foam Block Pullout, Static Torque to Failure, Static Cantilever Bending, Dynamic Cantilever Bending, and Driving Torque. Regarding ankle joint devices, results were collected for Range of Motion, Tibial and Talar Fatigue, Interlock, Constraint, Contact, and Wear testing. For the hip joint devices, results were collected for mechanical testing of acetabular components including Push-Out, Lever-Out, and Torque-Out testing. The ORCA database is significant because it stratifies typical ranges of values for a wide variety of devices into one comprehensive resource for FDA reviewers. This allows lead reviewers to effectively and efficiently compare new devices to a substantial collection of previously cleared devices and make confident decisions based on FDA precedent. Consistent regulation and decisions backed by data will facilitate innovation while allowing patients to receive safe and effective care.