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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, Makers Of Large Joint Implants Make It Personal

One attention-grabbing strategy at AAOS’ 2012 meeting 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.

At AAOS, Large Joint Makers Are Making It Personal

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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