Fusion Orthopedics Receives 510K FDA Approval on new Silastic System
Fusion Orthopedics is pleased to announce an expanded and new Silastic System as the newest addition to their product offering. FDA 510(k) clearance was issued October 21st, 2019. The assigned FDA 510(k) # for Silastic System is K190136.
The new Silastic System is largely influenced by our previously acquired and now wholly owned subsidiary company, Sgarlato Med. Sgarlato Med was founded in 1989 by Thomas E. Sgarlato, DPM, a renowned surgeon and pioneer in foot and ankle surgical and biomechanical methods. Throughout his career he was known for his research, innovative surgical techniques, extensive journal articles, books, and as an inventor of foot and ankle implants. Along with all those to whom Dr. Sgarlato contributed so much, we lament his passing on June 18th 2016. Our promise to carry forward the rich legacy he left behind has been our mission since acquiring Sgarlato Med.
The Silastic System is an expansion of the highly reputable systems created by Dr. Sgarlato. Not only will it include the well renowned Sgarlato GAIT Flexible 1st MPJ Implant with Grommets, SHIP Flexible PIP Rod now has 2 more sizes, and the original SHAW Flexible PIP Rod. Significant instrumentation upgrades have been completed across all systems.
This product category expansion now adds a GAIT 2.0 Implant with improved anatomical fitment with Grommets. The GAIT 2.0 includes market leading instrumentation to improve the speed of surgery while promoting reproducible results. We anticipate release of the GAIT 2.0 system in 2020.
Fusion has made significant strides improving and expanding Dr. Sgarlato’s Silastic System further. Surgeons will soon have the option of using the original GAIT Implant with or without Grommets with upgraded instrumentation.
This FDA clearance highlights the accelerating growth of Fusion Orthopedics. The company anticipates significant demand for the product as they round out a complete digital implant category solution with implants addressing most surgeon preferences.