Ossio, Inc.’s OSSIOfiber Compression Screws have received 510(k) clearance from the FDA.
The screws are indicated for "maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization," according to FDA clearance documents.
The company says the bio-integrative implant leaves no permanent hardware behind and is the "only compression screw on the market that combines the necessary strength for bone fixation with the ability to fully integrate into the surrounding anatomy without adverse foreign body reactions and stress shielding, and avoids potential patient discomfort or implant related complications that are often associated with permanent metal hardware."
Here is how the FDA clearance documents describe how "leave no hardware behind" is accomplished:
"Compression Screws are cannulated bone screws made of degradable poly (L-lactide-co-D, L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber™ implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery."
In an October 19, 2020 press release, the company said this is the third FDA clearance for its technology. To date, more than 1,000 OSSIOfiber implantations have been conducted in the U.S.
Tom San Giovanni, M.D., Director of Foot & Ankle Surgery, Department of Orthopedic Innovation at Miami Orthopedics & Sports Medicine Institute, is the surgeon who performed the 1,000th OSSIOfiber implantation as part of a first interphalangeal fusion of the hallux (great toe) procedure. “With compression screws being one of the most widely used fixation tools used today, OSSIO’s latest contribution to the fixation market shows real promise in successfully addressing multiple lower and upper extremity injuries.”
The company says studies show that implants made from their materials "provide easy insertion and secure fixation with rapid bone attachment" within two weeks after surgery, and "gradual, safe incorporation and complete integration into the surrounding anatomy within 18 to 24 months."
The compression screw portfolio will initially comprise a 4.0mm-diameter cannulated, headless, partially threaded compression screw in lengths ranging from 26mm to 60mm. The company plans to launch the screws in early 2021 and expand the portfolio in varying diameters (3.5-6.5mm), lengths and geometry.
Ossio, Inc., was founded in 2014 to provide the first credible replacement to metal implants in the multi-billion-dollar global orthopedic fixation market. Development headquarters are located in Caesarea, Israel, and commercial headquarters in Woburn, Massachusetts.
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