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Distal extremity device maker Centric Medical has a new FDA 510(k) clearance for its foot and ankle plating system.
The company, a division of Life Spine, Inc., announced on January 23, 2018, that the FDA clearance offers “multiple surgical solutions” by the company to be used in foot and ankle reconstruction procedures.
“The Centric Medical Foot and Ankle Plating System,” states a company press release, “is comprised of a variety of plates and screws intended to stabilize and fixate bone for a myriad of procedures. The low-profile plates and self-drilling and self-tapping screws were designed to minimize soft tissue disruption and irritation.
“They are offered in non-sterile, single use implantable components and are provided in a multitude of sizes and shapes which include plates specifically designed for metatarsal phalangeal fusions, lapidus fusions, midfoot fusions and calcaneal slide osteotomies.”
“When paired with our recently FDA cleared Cannulated Screw Internal Fixation System, and our existing OSTEO-LINK DBM biologics product, we have the potential for excellent clinical outcomes,” said Life Spine Vice President of Marketing Mariusz Knap. “As one of the fastest-growing, most innovative companies in our space it is crucial to our surgeons and patients that we continue to advance our offerings.”
Indications for Use
According to the FDA clearance notification, the system is indicated for use in “stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multifragmentary fractures; revision procedures, joint fusions, and reconstruction of the bones of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.”
For Further Information
More on the orthopedic trauma market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Trauma Devices. This report covers the following market segments: plate and screw, 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 series on the market for orthopedic trauma covers the U.S. 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 an U.S. Market Report Suite for Orthopedic Trauma Devices brochure and synopsis.