The new CMS-specific code is granted based on a preliminary benefit category determination that the Axor™ II Ossteointegrated External Prosthetic Connection Device is used in addition to a lower extremity prosthesis and, therefore, falls under the Medicare benefit for artificial legs (prosthetics). Since the Axor™ II utilizes a standard 4-hole male/female mounting system, the OPRA™ Implant System can be connected to commercially available prosthetic systems that utilize this standardized connection method. The Axor™ II acts like a ski-binding and releases the prosthesis if overload occurs, reducing the risk of damage to the implant and the skeleton.
 

"The new reimbursement code marks the start of a formalized reimbursement process for our prosthetics. A formalized process enables prosthetists to, in a consistent way, apply for reimbursement and reduces the potential risk associated with using products without a dedicated code. We expect the new code will significantly improve our offering to prosthetists and help to drive growth when the code takes effect in October," says Rickard Brånemark, CEO of Integrum.

Axor™ II was first approved under a Premarket Approval (PMA) application by the Food and Drug Administration (FDA) on December 18, 2020.