DEKA Robotic Arm Approved For Amputees

First prosthetic arm that can translates signals from person’s muscles to perform complex tasks

The Food and Drug Administration (FDA) has approved a robotic arm intended to restore function to people with upper extremity amputations. The DEKA Arm System, dubbed “Luke” for Luke Skywalker by its inventors, is the first prosthetic arm that can perform multiple, simultaneous movements that are controlled by electrical signals sent from the patient’s muscles.

How it Works

The electrical signals are captured by electromyogram (EMG) electrodes, which detect electrical activity caused by the contraction of muscles close to where the prosthesis is attached. “The electrodes send the electrical signals to a computer processor in the prosthesis that translates them to a specific movement or movements,” according to a press release from the FDA.

The DEKA arm resembles the shape and size of an adult arm. "This innovative prosthesis provides a new option for people with certain kinds of arm amputations,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “The DEKA Arm System may allow some people to perform more complex tasks than they can with current prostheses in a way that more closely resembles the natural motion of the arm.”

How it Was Approved

The FDA reviewed clinical information from 36 patients who used the DEKA arm to perform common household and grooming tasks. “The study found that approximately 90% of study participants were able to perform activities with the DEKA Arm System that they were not able to perform with their current prosthesis, such as using keys and locks, preparing food, feeding oneself, using zippers, and brushing and combing hair,” noted the agency.

The DEKA Arm System can be configured for people with limb loss occurring at the shoulder joint, mid-upper arm, or mid-lower arm. It cannot be configured for limb loss at the elbow or wrist joint. Data reviewed by the FDA also included testing of software and electrical and battery systems, mitigations to prevent or stop unintended movements of the arm and hand mechanisms, durability testing (such as ability to withstand exposure to common environmental factors such as dust and light rain), and impact testing.

"We are proud and excited that the FDA has approved the DEKA Arm System for commercialization," said Tom Doyon, Project Manager at DEKA. "This approval allows us to now focus on manufacturing and bringing to market the arm system so that we can deliver it to those in most need of this amazing technology—in particular our wounded veterans. This exciting breakthrough will allow amputees greater capability in their daily activities, both at home and at work, and greater freedom and independence," he noted in an email to Practical Pain Management

The DEKA Arm System is manufactured by DEKA Integrated Solutions in Manchester, New Hampshire.

Updated on: 11/05/20