FDA APPROVAL OF FIELD ORTHOPAEDICS MICROSCREW SYSTEM
The initial simulating process to make the small screw
The creation of instruments and kits making it possible
Announcing submission as to what product was needed by surgeons
Submission to the FDA in a world leading record breaking manner
Approval and market entry into the US, EU and Australia in 2019
17th July, 2018
Field Orthopaedics, a Brisbane based collaborative medical device company is please to announce after a lot of hard work, dedication and support, they have received the U.S Food and Drug Administration (FDA) approval for the Field Orthopaedics Micro Screw System. Field has gone from a start up with the idea stimulating process, to a medical device company that has just released it’s first novel and exciting product.
“This is an exciting and important milestone for extremity medicine, medical innovation and Australian medical devices” says CEO Dr. Chris Jeffery.
“What once seemed impossible to make, the 1.5mm screw with micro cannulation to allow precise insertion is now a product suitable for small fractures which was previously unaddressed in the medical field”.
The micro screw system is a user and patient driven system that will improve outcomes and has been designed to respond to the problems expressed by the orthopaedic surgeon.
“This fills a gap and fulfills company philosophy of identifying problems and optimising treatment options for small fractures in the hand” says Lead Design Surgeon of Field Orthopaedics, Dr. Greg Couzens.
Submission of the Micro Screw System was submitted to the FDA in a world-breaking manner that came after months of dedicated work from all involved to turn the idea into a viable market product.
The recent approval is the land mark milestone that is the green light to now commence market entrance to the US before submitting approval to the EU before the end of the year. Whilst there will be sporadic entry in the interim, the primary global roll out for the Micro Screw System will be complete with the product reentering back in Australia next year.
Dr. Chris Jeffery
CEO Field Orthopaedics
+61 401 249 783
About Field Orthopaedics
Field Orthopaedics is a Brisbane based collaborative medical device company making a difference and finding problems work solving medicine. It unpacks problems and looks them in a way they haven’t been looked at before. Working with all aspects of the medical community we collaborate to innovate.
Learn more about Field Orthopaedics: www.fieldorthopaedics.com