Field Orthopaedics gets FDA approval for world’s smallest orthopaedic screw

The Brisbane-based designer of the world’s smallest orthopaedic screw has invoiced US hospital suppliers $900,000 in the three weeks since the device gained Food & Drug Administration approval, and he hopes it can soon be made in Brisbane too.

Field Orthopaedics, founded in 2016 by former Army doctor Chris Jeffery alongside a team of doctors and engineers including hand surgeon Greg Couzens, has spent $600,000 and 18 months taking its “micro screw” from concept to FDA clearance, which was officially granted on July 17.

This compares with the average $39 million and 31 months that medical device makers in the micro screws’ low-to-moderate risk category (or 510-k in FDA jargon) spend getting approval, according to a major Stanford University study from 2010.