Is Software-Guided Surgery New?


Since the 1980s, surgeons have been using surgical navigation to create an accurate model of the patient anatomy. The system software is used to help assess the case, plan the surgery and actually mirror the real human anatomy on screen. This system helps guide the surgery and the surgical instruments being used for the procedure. Used in knee arthroplasty, software-guided surgery is typically performed without any images such as X-ray, MRI or CT, beyond those that are used for diagnosis and planning. In knee replacement surgery, software-guided surgery systems are used to help assist in straight alignment and more accurate implant placement compared to conventional surgery.1

In orthopedic surgery, software-guided systems have been used for more than 15 years now, making them an established and well-known addition to hip and knee procedures worldwide. Today, surgeons use software-guided systems with mobile—sometimes even handheld—devices. For example, Dash®, a handheld surgical navigation system from Brainlab, uses an iPod® touch®, as its monitor directly at the surgical site.2

The navigation system does not take the place of your doctor, but is rather a guiding tool used during surgery. Surgical navigation enables your doctor to plan your hip procedure before surgery and helps guide the surgeon’s instruments during surgery.

Is surgical navigation subject to FDA approval?

The Food and Drug Administration (FDA) is responsible for ensuring public safety by regulating medical devices. Surgical navigation systems are considered medical devices and therefore are subject to review and clearance by the FDA.

Is surgical navigation covered by insurance?

As you may already know, insurance companies pay hospitals per procedure, including all goods used in that procedure, so each case is different depending on the insurance company and hospital. Hospitals and surgeons who use software-guided technology during the surgical procedure often build the costs of navigation into their total costs for the procedure.
® 2014 Brainlab AG and Brainlab Inc. All rights reserved.
® 2014 Brainlab AG and Brainlab Inc. All rights reserved.
® iPad, iPod and iPhone are registered trademarks of Apple Inc.


1 ‘Clinical outcome using a ligament referencing technique in CAS versus conventional technique.’ Knee Surg Sports Traumatol Arthrosc. 2010; Sept 18; Lehnen K. et al.

2 Mezger U, Jendrewski C, Bartels M. Navigation in surgery. Langenbecks Arch Surg. 2013 Apr; 398(4):501-14