The Distalock Titanium Femoral Intramedullary Nail system, developed by DGIMed Ortho, has received 510(k) clearance from the US Food and Drug Administration (FDA).
The system includes the Distalock drill, which offers the surgeon a unique and innovative approach to ensuring the accurate placement of the distal locking screws used to stabilise the rod-like implants for treating long-bone fractures.
The Distalock system facilitates fast and accurate placement of the distal locking screws, while reducing or eliminating the use of X-rays required with standard techniques.
The system also reduces procedure time, lowering surgery facility and staff costs.
DGIMed Ortho president and CEO Phil Smith said the next step will be a limited launch in certain domestic markets this summer and a focus on efforts adapting nail and drill system for use with tibia fractures.
“Distalock can reduce occupational exposure to radiation in medicine and positively impact the safety of the surgeon, operating room staff and the patient,” Smith said.