Hip and Spine: New Players Receive FDA 510(k)s

Of the 56 orthopaedic-related 510(k)s that FDA released in June 2017, I’d like to share some observations on just four:

  • Two total hips that we’ve been waiting for: one from ConforMIS and one from Medtronic
  • Two spine products: one interbody (SAGICO) and a pedicle screw system (Phamedica)—more on these in a moment.

We’ve been expecting the ConforMIS iTotal hip clearance since the company withdrew its original application and resubmitted it in 2H16. ConforMIS seeks to apply the formula that it uses for knees—complete customization of implants and a reproducible surgical technique—to the hip.

We’ve awaited the Medtronic hip since they acquired Responsive Orthopedics—a start-up focused on low-cost hip and knee replacements—about a year ago. The knee has already cleared and launched, but very little light has been shone on uptake of the company’s orthopaedic program, so far. My hope is that this second product clearance and subsequent launch will get some buzz going; leadership has promised to talk about it this year. ~ Read more>>

August 1st, 2017|Categories: Industry News|