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DGIMED Receives FDA Approval For Drill and Intramedullary Nail System

A new approach to ensure the accurate placement of the distal locking screws

DGIMED Ortho (DGIMED) has received 510(k) approval from FDA for its Drill and Intramedullary (IM) Nail system.

The company claims that this Drill system uses a new approach to ensure the accurate placement of the distal locking screws used to stabilize the rod-like implants in long bone fractures of the femur and tibia.

The proprietary system is designed to improve clinical outcomes by facilitating faster and more accurate placement of distal locking screws, while reducing the amount of x-ray required with most placement techniques.

As a result, procedure time should be significantly reduced, lowering surgery facility and staff costs and reducing radiation exposure for the orthopedic surgeon, hospital staff, and the patient, said the company.

Phil Smith, president and CEO of DGIMED, said: “This timely notification keeps us on track as we now plan to initiate our market validation work to gain additional feedback on our system. This will significantly contribute to our continued development of the next generation DISTALOCK Drill and IM Nail system.”