ExsoMed Gains FDA Clearance of InFrame Intramedullary Micro Nail for Proximal Phalanx Fractures

By Julie A. Vetalice

ExsoMed Gains FDA Clearance of InFrame Intramedullary Micro Nail for Proximal Phalanx Fractures

ExsoMed received FDA 510(k) clearance to market the InFrame™ Intramedullary Micro Nail. Product launch will commence in 4Q20 for the sterile-packed, single-use system.

InFrame is reportedly the first permanent stable intramedullary fixation device that controls rotation, allowing phalanges to resume immediate motion and tendon gliding.

InFrame is designed and sized specifically for the proximal phalanx intramedullary canal to facilitate early, active mobilization for accelerated healing and faster return to daily activities. The 2.0mm diameter design provides surgeons with the ability to easily achieve cross implantation constructs, enhancing rotational control and stability, cortical bone purchase and intramedullary fit.

Statistically significant internal bench test data has shown that InFrame has superior construct stability vs. to traditional approaches for proximal phalanx fractures. InFrame provided 97% more bending stability and 341% more rotational stability than two crossed 0.045” K-wires; 473% more bending stability and 280% more rotational stability than dorsal plates and screws; and 48% more bending stability and 1,533% more rotational stability than headless compression screws.

“Surgeons have shared with us on numerous occasions that an effective solution for P1 fractures is desperately needed in the hand surgery space,” shared James Young Kim, ExsoMed’s Managing Director of Global Sales and Marketing. “We have answered their calls and are proud to introduce InFrame.”

ExsoMed recently completed its second round of financing, which will support surgeon education and 2020 and early 2021 product launches.

Product Labels: Upper Extremity

Tags: 510(k) Clearance, Regulatory