ExtremitiesRegulatory

Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Reduced Size Foot Plating System

WARSAW, IND. (PRWEB) JULY 31, 2020

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., today announced it has received 510(k) clearance by the Food & Drug Administration to market its upcoming Stratum® RS (Reduced Size) Foot Plating System.

“The Stratum RS Foot Plating System optimizes sizing and profiles for applications in the forefoot while leveraging the Stratum technology. We are excited to bring this Stratum system expansion to market, providing our customers even more options throughout the foot,” said Adam Finley, Director of Product Development, Reconstruction for Nextremity Solutions.

The Stratum RS System builds on the success of the Stratum Foot Plating System that launched in 2019. The system includes 18 different plates that are designed to fit various anatomies in smaller patients. This includes Single Lisfranc, Peanut, Straight, Hockey Stick, L-shaped, Y-shaped, and T-shaped plates. This expansion of the Stratum brand will result in close to 70 options to treat deformities and fractures in the human foot. The system also includes a single-use disposable instrument kit which eliminates the need for sterilization by hospitals, as well as providing surgeons with brand new instrumentation at every case.

Ryan Schlotterback, Chief Technology Officer for Nextremity Solutions said, “We’ve been very pleased with the performance and adoption of our Stratum Foot Plating System. Our new Stratum RS is a wonderful complement to our existing system and will be very familiar to our surgeon customers in both product technology and overall surgical efficiency. The team continues to work hard with our surgeon partners to accelerate the expansion of the Stratum portfolio and we look forward to addressing other anatomical applications.”

“Once again we are extremely proud of our team as we achieved another significant milestone with this approval. We look forward to continuing the momentum that the Stratum Plating System is achieving in the market with the addition of the Stratum RS,” President & CEO, Rod K. Mayer added.

The Nextremity Solutions Stratum RS Foot Plating System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the foot and ankle, particularly in osteopenic bone.

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.

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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