NuVasive Receives Expanded FDA 510(k) Clearance for PRECICE

By Julie A. Vetalice

NuVasive (NUVA) received expanded FDA 510(k) clearance for NuVasive Specialized Orthopedics' PRECICE® limb lengthening system. Building on previous indications for limb lengthening in the femur and tibia, PRECICE indications now include open and closed fracture fixation, pseudoarthrosis, malunion, nonunion and bone transport, a technique used to fill segmental tissue loss in long bones following trauma or infection.

PRECICE comprises an external remote controller that guides an intramedullary device to non-invasively compress and distract long bones. These new indications allow NUVA to expand its platforms and grow in limb recon and trauma markets.

An online resource, Reach Your Height, is also now available with patient education and success stories in the treatment of limb length discrepancy.

Source: NuVasive, Inc.

Product Labels: Lower Extremity

Tags: 510(k) Clearance, Regulatory