OSSIO Inc. has launched OSSIOfiber small compression staples for use in both hand and foot procedures, particularly for bunion repair with a surgical technique known as the Akin osteotomy.
 
Bradley Lamm, D.P.M., director of the Foot and Ankle Deformity Center at the Paley Institute in West Palm Beach, Fla.; and Selene Parekh, M.D., a professor of orthopedic surgery specializing in foot and ankle procedures at the Rothman Institute in Princeton, N.J., and Philadelphia, were among the first clinicians to use the new staples in an Akin bunion procedure.
 
“By design, OSSIOfiber small compression staples are remarkably easy to insert during Akin bunion repair,” Lamm said. “This new OSSIOfiber product line increases the opportunities for surgeons to use a fixation technology that is replaced by bone over time, without the inherent risks of metal implants. Patients appreciate the no-metal footprint just as much as we surgeons do.”
 
“I have used several different small compression staples during my many years as a foot and ankle surgeon,” Parekh added. “For me, the most important reason to use OSSIOfiber bio-integrative implants in orthopedic surgery is the opportunity to dispense with metal without sacrificing compression strength. Not having to worry about hardware irritation after an Akin bunion repair and the need for a secondary surgery is extremely attractive to patient and surgeon alike.”
 
Cleared by the U.S. Food and Drug Administration (FDA) in November 2023, OSSIOfiber small compression staples—the company’s latest offering for orthopedic fixation―expands the company’s product portfolio, which already includes larger compression staples, as well as suture anchors, compression screws, trimmable fixation nails, and a hammertoe fixation system.
 
OSSIOfiber implants are made with the same bio-integrative fiber matrix, a revolutionary advance in material science, according to the company. Combining this highly differentiated technology with instrumentation, OSSIOfiber small compression staples were intentionally designed for ease of use, for compression strength that matches or exceeds nitinol staples, and with all the advantages of a non-permanent implant that patients prefer.
 
“Our mission at OSSIO is nothing less than transforming the experience of patients who must undergo orthopedic surgery where internal fixation is required,” OSSIO CEO Brian Verrier stated. “With more than 40,000 OSSIOfiber implants performed to date, just five years since commercializing our first product in 2019, we launch this new small compression staple platform, further expanding patient access to a metal-free alternative for orthopedic fixation.”
 
OSSIOfiber small compression staples are used to repair arthrodesis, osteotomies, and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization. The number and size of the OSSIOfiber staples must be adapted to the indication.
 
OSSIOfiber relies on Intelligent Bone Regeneration Technology, which the company touts as a breakthrough in fixation material that provides the first credible solution to the shortcomings of permanent metal hardware, conventional absorbable and allograft implants; it combines mechanical strength and natural bone healing in a non-permanent implant. Made from a proprietary mineral fiber matrix held together by a bio-friendly polymer, OSSIOfiber implants feature bio-integrative material properties that provide surgeons with a more biologically friendly way to restore patients’ stability and mobility while leaving nothing permanent behind.
 
Designed for rapid bone in-growth, regeneration and replacement, OSSIOfiber Intelligent Bone Regeneration Technology is a first-of-its-kind implant material stronger than cortical bone. It is engineered to provide the strength required for functional fixation while allowing for full integration into patients’ native anatomy without adverse biological response and can address many surgical applications through the manufacturing of endless implant designs, including nails, screws, staples, anchors and plates.
 
OSSIO intends to pursue multiple applications for OSSIOfiber implants in all major segments of orthopedics such as foot and ankle, hand and wrist, upper extremity and trauma, pediatrics, sports medicine, and reconstruction.
 
OSSIOfiber implants use existing reimbursement codes and surgical techniques.
 
OSSIO is an orthopedic fixation company aims to transform the surgical experience for patients, physicians, providers, and payors. Founded in 2014, the company is working to provide the first credible replacement for metal implants in the multibillion-dollar global orthopedic fixation market with OSSIOfiber Intelligent Bone Regeneration Technology. OSSIO’s R&D headquarters is in Caesarea, Israel, and its commercial headquarters is based in Woburn, Mass.