Field Orthopaedics received FDA 510(k) clearance to market a micro screw system for fixation of fractures, osteotomies and arthrodeses of small bones in the foot, hand and forearm.
The FO Micro Screw Kit includes 1.5mm and 2.0mm diameter cannulated compression screws with lengths ranging from 6mm to 16mm in 1mm increments. The system comprises trays of 200 screws plus insertion equipment, available wholesale to distributors for $20,000; alternatively, they can pay a $2,000/month subscription to have the kits replaced each time the design team creates an upgrade.
Field Ortho reportedly spent $600,000 and 18 months moving the screw from concept to clearance, and has outsourced most elements of U.S. distribution to Ortho Sales Partners. Future products include a range of power tools and a bone cement designed to eliminate infection following orthopaedic procedures.
Sources: Australian Financial Review; FDA.gov
Field Orthopaedics received FDA 510(k) clearance to market a micro screw system for fixation of fractures, osteotomies and arthrodeses of small bones in the foot, hand and forearm.
The FO Micro Screw Kit includes 1.5mm and 2.0mm diameter cannulated compression screws with lengths ranging from 6mm to 16mm in 1mm increments. The system comprises...
Field Orthopaedics received FDA 510(k) clearance to market a micro screw system for fixation of fractures, osteotomies and arthrodeses of small bones in the foot, hand and forearm.
The FO Micro Screw Kit includes 1.5mm and 2.0mm diameter cannulated compression screws with lengths ranging from 6mm to 16mm in 1mm increments. The system comprises trays of 200 screws plus insertion equipment, available wholesale to distributors for $20,000; alternatively, they can pay a $2,000/month subscription to have the kits replaced each time the design team creates an upgrade.
Field Ortho reportedly spent $600,000 and 18 months moving the screw from concept to clearance, and has outsourced most elements of U.S. distribution to Ortho Sales Partners. Future products include a range of power tools and a bone cement designed to eliminate infection following orthopaedic procedures.
Sources: Australian Financial Review; FDA.gov
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.