t’s not going out on a limb when you’ve tested and retested…Small Bone Innovations, Inc. (SBi) has announced that after extensive evaluations by foot and ankle surgeons, it has received 510(k) pre-market clearance notifications from the FDA for Mini-Rail Fixation System (‘Mini-Rail System’) and large Cannulated Screw System for use in lower limb reconstruction and repair procedures.
SBi expects its Mini-Rail System to be used in common procedures such as first MTP (metatarsophalangeal) joint arthrodesis and distraction, subtalar fusion, and Jones fracture management. There are approximately 65,000 of these procedures performed annually in the U.S.
As indicated by the company, the Mini-Rail System is a unique and highly adjustable fixation system that lets surgeons quickly achieve optimal placement in the bones of fixation “half” pins. SBi also notes that the system’s ease of use can decrease OR time.
Guido LaPorta, DPM, FACFAS, Chief of Foot and Ankle Surgery at Community Medical Center, Scranton Pennsylvania., said in the news release, “The SBi Mini-Rail System offers a versatile solution for small bone reconstruction and trauma. The system’s design allows it to be used as primary or complementary fixation in arthrodesis, osteotomy, bone lengthening and fracture repair. The system’s unique instrumentation allows us to employ the Mini-Rail System as an anatomically accurate and rigid construct.”
As for the large Cannulated Screw System (made out of stainless steel), SBi expects it to be used for a variety of foot and ankle procedures including triple arthrodesis, subtalar and ankle fusions. There are approximately 50,000 of these procedures performed annually in the U.S.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said in the news release, “Both the Mini-Rail and large Cannulated Screw systems have been designed specifically for use in a wide range of lower limb procedures to reinforce and enhance the company’s goal of developing the most attractive, anatomically-focused product portfolio available for use by foot and ankle surgeons. These systems reinforce SBi’s commitment to work with key opinion leaders to provide product solutions that serve the full range of clinical needs of surgeons and their patients.”
It’s not going out on a limb when you’ve tested and retested…Small Bone Innovations, Inc. (SBi) has announced that after extensive evaluations by foot and ankle surgeons, it has received 510(k) pre-market clearance notifications from the FDA for Mini-Rail Fixation System (‘Mini-Rail System’) and large Cannulated Screw System for use in lower limb reconstruction and repair procedures.
SBi expects its Mini-Rail System to be used in common procedures such as first MTP (metatarsophalangeal) joint arthrodesis and distraction, subtalar fusion, and Jones fracture management. There are approximately 65,000 of these procedures performed annually in the U.S.
As indicated by the company, the Mini-Rail System is a unique and highly adjustable fixation system that lets surgeons quickly achieve optimal placement in the bones of fixation “half” pins. SBi also notes that the system’s ease of use can decrease OR time.
Guido LaPorta, DPM, FACFAS, Chief of Foot and Ankle Surgery at Community Medical Center, Scranton Pennsylvania., said in the news release, “The SBi Mini-Rail System offers a versatile solution for small bone reconstruction and trauma. The system’s design allows it to be used as primary or complementary fixation in arthrodesis, osteotomy, bone lengthening and fracture repair. The system’s unique instrumentation allows us to employ the Mini-Rail System as an anatomically accurate and rigid construct.”
As for the large Cannulated Screw System (made out of stainless steel), SBi expects it to be used for a variety of foot and ankle procedures including triple arthrodesis, subtalar and ankle fusions. There are approximately 50,000 of these procedures performed annually in the U.S.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said in the news release, “Both the Mini-Rail and large Cannulated Screw systems have been designed specifically for use in a wide range of lower limb procedures to reinforce and enhance the company’s goal of developing the most attractive, anatomically-focused product portfolio available for use by foot and ankle surgeons. These systems reinforce SBi’s commitment to work with key opinion leaders to provide product solutions that serve the full range of clinical needs of surgeons and their patients.”
http://ryortho.com/extremities.php?news=442_510k-for-SBi
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