Direct bone-anchorage
The OPRA® Implant System is a bone-anchored system based on osseointegration where the OPRA® Implant is directly attached to the bone and thus avoiding the use of socket. The system utilizes a modular design consisting of three main parts that have been developed and refined over the years based on many years of development and clinical research. The unique design is designed to help protect the patient in an effort to avoid bone fractures from accidental loads. The implant components are inserted surgically into the bone of the residual limb in one or two surgical procedures.
Fixture
Anchoring element inserted into the patient’s bone
Abutment
Skin penetrating connection attached to the Fixture
Abutment Screw
A screw made of titanium alloy that locks the Abutment to the Fixture
The OPRA® Implant System was CE marked in 1999 and is currently approved under EU Medical Device Regulation (MDR) for transfemoral, transhumeral, and digit amputations. And is also available and approved for use in the UK, Australia, Ukraine and Israel.
The OPRA® Implant System received FDA Humanitarian Device Exemption (HDE) in 2015 and Premarket Approval (PMA) in 2020 for individuals with above-the-knee (transfemoral) amputation.
