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Materialise Receives FDA NSE Letter for X-ray Knee Guide 510(k) Submission

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Materialise received a Not Substantially Equivalent letter from FDA regarding the 510(k) submission for its X-ray knee guide. The system is intended for use as a surgical instrument to assist in the positioning of total knee replacement components, without MRI or CT.

Source: Materialise

FDA clarified its substantial equivalence requirements for 510(k) submissions in 2014. At OMTEC® 2015, Constance Soves of FDA’s Division of Orthopedic Devices, Office of Device Evaluation, spoke on best practices for 510(k) submissions. Review a summary of her recommendations and download her presentation slides in PDF format here.