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First Ray, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for new additions to the Stealth Staple™ System product family.
Previously, the company received clearance for its “Standard” size implants in different lengths, manufactured from titanium alloy. The new FDA clearance includes: “Standard” size implants manufactured from PEEK, “Small” size implants manufactured from titanium alloy or PEEK, and “Mini” size implants manufactured from titanium alloy. Standard size implants are well suited for hindfoot fusions and first tarsometatarsal joint fusions. Small size implants are well suited for midfoot fusions, first metatarsophalangeal fusions and carpal fusions. Mini size implants are well suited for carpometacarpal joint fusions, lesser metatarsophalangeal fusions, and fixation of Akin osteotomies. Surgeons now have the choice for radiopaque and, for the Standard and Small sizes, radiolucent implants.
The Stealth Staple™ System, an intraosseous small bone fixation system, represents a significant advancement for the treatment of arthrodesis, osteotomies and bone fractures. Current standard-of-care devices used to treat these indications are primarily bone plates and bone screws, or bone staples. Due to the prominence above the bone surface associated with these standard-of-care devices, there are notable clinical rates of device related pain, soft tissue irritation, and second surgeries for hardware removal. Since the Stealth Staple™ is completely contained within the bone upon implantation, clinical complications related to prominent hardware may be substantially reduced.
Another significant advancement provided by the Stealth Staple™ is the creation of controlled and evenly distributed compression across the opposing bone surfaces of an osteotomy or fracture. Finite element analysis and biomechanical testing have demonstrated superior strength, superior bone compression and superior resistance to gap formation compared to bone plate and screw systems (data on file).
First Ray is a development stage medical device company incubated and operated by Surgical Frontiers. Inquiries regarding distribution and commercialization partnerships are welcome.
For Further Information
More on the orthopedic trauma device market in the U.S. can be found in a series of reports published by iData Research entitled the US Market Report Suite for Orthopedic Trauma Devices 2017. The suite covers reports on the following markets: plates and screws, bioabsorbable trauma fixation, intramedullary nails, cannulated screws, intramedullary hip nails, conventional hip fixation, bone staples, bone pins, external fixation and bone growth stimulators.
The iData report series on orthopedic trauma devices covers the U.S., Brazil, Japan, China, India and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedic trauma device market data or procedure data, register online or email us at [email protected] for a US Market Report Suite for Orthopedic Trauma Devices 2017 brochure and synopsis.
About iData Research
iData Research is an international market research and consulting firm, dedicated to providing the best in business intelligence for the medical device industry. Our research empowers our clients by providing them with the necessary tools to achieve their goals and do it right the first time. iData covers research in: Laparoscopy, Urology, Gynecology, Endoscopy, Dental Operatory Equipment, Dental Material, Dental Lasers, Dental Prosthetics, Dental CAD/CAM, Dental Bone Graft Substitutes, Ophthalmics, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Vascular Access, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics and more.
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