FDA clears Conformis’ iTotal hip replacement (MassDevice)
ConforMIS (NSDQ:CFMS) said today it won FDA 510(k) clearance for its primary iTotal Hip replacement system.
The iTotal Hip system features the company’s iFit technology which uses single-use, custom 3D printed instruments and a limited amount of reusable instruments to deliver a customized hip replacement, the Billerica, Mass.-based company said.
“Standard hip replacement surgery can be challenging, presenting risks of dislocation, discrepancies in leg length and limited reproducibility. With the ability to achieve a better match to a p...
