Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Ankle Fusion Plating System
"The Stratum Ankle Fusion System is a comprehensive system of anatomical plates to provide surgeons anterior, lateral and posterior fusion options.
WARSAW, Ind., Dec. 20, 2021 /PRNewswire-PRWeb/ -- Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the extremity musculoskeletal space, located in "The Orthopedic Capital of the World," Warsaw, Ind., announced it has received 510(k) clearance by the Food & Drug Administration to market its upcoming Stratum® Ankle Fusion Plating System.
"The Stratum Ankle Fusion System is a comprehensive system of anatomical plates to provide surgeons anterior, lateral and posterior fusion options. The design team has done an outstanding job identifying the obstacles that plague current ankle fusion cases and developing innovative solutions to meet those unmet needs," said Adam Finley, Director of Product Development for Nextremity Solutions.
The Stratum Ankle Fusion Plating System is just one more addition to the Stratum brand of plating systems for the foot and ankle. The previous launches of both the Stratum Foot Plating System, as well as the Stratum Reduced Size Foot Plating System have proven to address the needs of surgeons in the marketplace. This expansion of the Stratum brand will result in close to 90 options to treat deformities and fractures in the human foot and ankle.
Ryan Schlotterback, Chief Technology Officer for Nextremity Solutions commented, "It has been a pleasure for our team to work with a group of key surgeons from around the globe to develop our Stratum Ankle Fusion Plating System. This is a really comprehensive system and incorporates the unique on-plate compression that Stratum is known for. We look forward to continuing to expand the Stratum brand and meet the needs of our surgeon partners."
"As a company that is resolutely committed to the development of surgeon-driven technologies, I couldn't be prouder of our team in this most recent achievement," added President & CEO, Rod K. Mayer.
The Nextremity Solutions Stratum Ankle Fusion Plating System is indicated for stabilization and fixation of fractures or osteotomies, intra and extra articular fractures, and multi-fragmentary fractures, revision procedures, non-union and malunion, joint fusion and reconstruction of small bones of the feet and ankles including the distal tibia, talus, and calcaneus.
About Nextremity Solutions, Inc.
Nextremity Solutions, Inc. is a privately-held strategic commercialization organization in the musculoskeletal space, offering innovative solutions and Revenue Ready products for various musculoskeletal applications and for the benefit of its industry partners. The Company's procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.
Media Contact
Dave Temple, Nextremity Solutions, Inc., +1 574-635-3022, [email protected]
SOURCE Nextremity Solutions, Inc.
