MINNETONKA, Minn.–(BUSINESS WIRE)– DGIMED ORTHO, Inc. announced today that the company has received notification of clearance of its 510(k) submission for the DISTALOCKTM Titanium Femoral Intramedullary Nail system. In November 2009, the Company also received its initial clearance on the DISTALOCKTM Drill system with a stainless steel femoral IM nail.
The system includes the proprietary DISTALOCKTM drill, which offers the surgeon a unique and innovative approach to ensuring the accurate placement of the distal locking screws used to stabilize the rod-like implants used to treat long-bone fractures. The DISTALOCKTM system is designed to improve clinical outcomes by facilitating fast and accurate placement of the distal locking screws, while reducing or eliminating the use of x-ray required with standard techniques. As a result, procedure time may be significantly reduced, lowering surgery facility and staff costs. [must make sure that this sentence is consistent with claims cleared by FDA]
“This notification is very timely for us. Our next step will be a limited launch in certain domestic markets this summer and we will focus our product development efforts on adapting our nail and drill system for use with tibia fractures.” said Phil Smith, the company’s President and CEO. “There is a growing awareness of occupational exposure to radiation in medicine, and it is widely recognized that standard distal targeting techniques are a significant contributor to the exposure of radiation to the orthopaedic surgeon. Our system can reduce this exposure and positively impact the safety of the surgeon, operating room staff and the patient.”
DGIMED ORTHO, Inc. is an early-stage medical device company that specializes in a new, proprietary system to assist orthopaedic surgeons in the delivery and distal locking of long-bone intramedullary nails. The company is located at 12400 Whitewater Drive, Suite 2010, Minnetonka, MN, 55343. www.dgimedortho.com