This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name:  Osseonachored Prostheses for Rehabiliation of Amputees (OPRA)TM Implant System
PMA Applicant:  Integrum AB
Address:  Krokslätts Fabriker 50, SE-431 37 Mölndal, Sweden
Approval Date:   December 18, 2020
Approval Letter:  Approval Order

What is it? 

The OPRATM Implant System is an Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) device and composed of parts that allow a prosthesis to attach directly to the femur (thigh bone).

How does it work? 

The OPRATM Implant System is installed with two surgeries. In the first surgery, a doctor puts a cylinder-shaped fixture into the center canal of the remaning thigh bone. Approximately six months later, after tissue has grown to anchor the fixture and the skin has healed, the doctor attaches more device parts at the same area. in the second surgery. The OPRATM Implant System extends through the skin at the bottom of the patient’s remaining limb to connect to the prosthesis.

When is it used? 

The OPRATM Implant System is intended for use in patients with above-the-knee amputations due to trauma or cancer and who have or are anticipated to have rehabilitation problems with, or cannot use, a convetional socket  leg prosthesis.

What will it accomplish? 

The OPRATM Implant System may reduce problems of leg prothesis attachment and improve how the prosthesis works. However, this device will not completely replace a lost leg. In a clinical study of 65 patients who received the OPRATM Implant System, the average prosthetic use score (a patient reported outcome measure that reflects frequency of prosthetic use) on a 100-point scale ) increased by 35.1 points at two years and by 39.6 points at five years as compared to their reported scores with a conventional socket prosthesis.

When should it not be used? 

The OPRATM Implant System should not be used in patients who:

• Are still experiencing bone growth
• Have different bone structures that might affect treatment, including:
  • Bone measurements outside the device’s acceptable measurement
  • Growth and development that is not normal
  • Conditions that may prevent the device from being put in correctly, such as deformities, fractures, or infections
• Have less than 2 millimeters (mm) of remaining cortex (outer layer) bone available around the implant after it is implanted
• Have osteoporosis (weak bones)
• Are older than 65 years or younger than 22 years
• Have body weight higher than 220 pounds including the device
• Are pregnant
• Are not expected to or able to follow treatment and follow up requirements
• Have the following pre-existing conditions:
  • Severe peripheral vascular disease
  • Diabetes mellitus with complications
  • Skin disorders that involve the leg
  • Neuropathy or neuropathic disease and severe phantom pain
  • Active infection or inactive bacteria
  • Metabolic bone disease or metastatic lesions (such as cancer) in the femur

Additional information (including warnings, precautions, and adverse events): 

• Summary of Safety and Effectiveness Data (SSED)
• Physician Labeling
• Patient Labeling
• FDA Approves Prosthetic Implant for Above-the-Knee Amputations
• PMA Database Entry
• News Release: FDA Approves Prosthetic Implant Above Knee Amputations