Biomet has received the US Food and Drug Administration (FDA) 510(k) clearance to market its Signature Personalized Patient Care System in the US.
The Signature system provides patient-matched guides for use in total knee replacement surgery paired with Biomet implants, combining MRI or CT images for each patient with advanced surgical planning software and manufacturing techniques.
The FDA granted the 510(k) clearance in a letter sent to Materialise NV, the manufacturer of the Signature system.
At Biomet’s request, Materialise sought the 510(k) clearance to resolve the issues the FDA raised in a warning letter sent to Biomet on 27 July 2010.
Biomet president and CEO Jeff Binder said the company cooperated fully with the FDA to resolve this matter in the best interests of patients, and are pleased with the outcome.
"This clearance paves the way for future submissions on the application of Signature technology to the treatment of other orthopedic conditions," Binder said.