Le Lézard
Classified in: Health
Subject: FDA

Additive Orthopaedics Announces FDA Clearance of their Minimally-Invasive, Intramedullary 3D Printed Bunion Correction System for the Extremities Market

LITTLE SILVER, N.J., June 21, 2017 /PRNewswire/ -- Additive Orthopaedics, LLC., an orthopaedic device company, today announced that is has received FDA 510(k) clearance for its 3D printed minimally-invasive, intramedullary Bunion Correction System, to address alignment and stabilization of bunions. 

Additive Orthopaedics Logo

According to Dr. Selene Parekh, Professor of Surgery in the Department of Orthopaedic Surgery at Duke Orthopaedics and North Carolina Orthopaedic Clinic, "This new 3D printed implant allows us to have features in plates that we cannot get with standard manufacturing processes. Namely, it allows an area of the plate to provide additional fixation and strength over time enabling bone to grow onto and through the plate. The hope is that a feature like this will allow for more reliable integration and alignment of bones following a bunion procedure." 

This is the Company's fourth 510(k) clearance leveraging additive manufacturing and 6th complete product line, which includes their 3D printed core products, biologics, and customs for limb salvage and complex revision cases.  Surgeons have implanted over 400 of their individual devices since the first full commercial product launch at the end of 2016.  The Company has recently closed a Series A Round of $1M.  

About Additive Orthopaedics, LLC.

Additive Orthopaedics is an early stage orthopaedic company focused on the integration of advanced manufacturing and biologics for the benefit of a better patient outcome. 

Greg Kowalczyk

SOURCE Additive Orthopaedics, LLC.

These press releases may also interest you

at 03:00
BEVERLY HILLS, Calif., March 24, 2018 /PRNewswire-PRWeb/ -- ProstaGenix, named World's Best Prostate Supplement in 2017, proves effective not only by the National Health Federation and Prostatepillreport.com, but by the raving customer reviews...

23 mar 2018
Kahn Swick & Foti, LLC ("KSF") and KSF partner, former Attorney General of Louisiana, Charles C. Foti, Jr., remind investors that they have until May 14, 2018 to file lead plaintiff applications in a securities class action lawsuit against Acadia...

23 mar 2018
WASHINGTON, March 23, 2018 /PRNewswire-PRWeb/ -- The Elizabeth Dole Foundation released the following statement today on the passage and signing of the omnibus spending bill: "Those of us who care deeply about military and veteran caregivers ? the...

23 mar 2018
Live Oak Village At Hammond Senior Living is now under new ownership and management and has been re-named Oak Park Village At Hammond Assisted Living and Memory Care after an extensive community renovation and upgrade to its offerings and amenities....

23 mar 2018
Arena Pharmaceuticals, Inc. today announced that Amit D. Munshi, the Company's President and Chief Executive Officer, will present a corporate update at the 17th Annual Needham Healthcare Conference on Tuesday, March 27 at 3:00 p.m. EDT.  The...

23 mar 2018
The Honourable Ginette Petitpas Taylor, Federal Minister of Health, will be announcing federal measures to increase access to opioid treatment. Government of Canada officials will also hold a media technical briefing (teleconference only) following...

News published on 21 june 2017 at 10:34 and distributed by: