FDA Warning Letters Target Personalized Knee Surgery Systems
This article was originally published in The Gray Sheet
Executive Summary
FDA's device center is warning two different orthopedic firms that the companies' personalized knee surgery instrumentation systems are being marketed without proper clearance or approval
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At AAOS’ 2012 meeting, one attention-grabbing strategy centered on the personalization of large joint implants to match the specific anatomies of patients. Several large joint manufacturers have introduced tools for achieving “custom fits” for new joints, knees in particular. Advances in robotics and customized manufacturing are enabling smaller companies to take personalization to the next step. MAKO featured its MAKOplasty Total Hip Arthroplasty (MAKOplasty THA), an advancement of its partial knee MAKOplasty procedure. In another approach toward customizing knee surgeries, ConforMIS manufactures a line of knee implants that are custom made for each individual patient.
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