Small Bone Innovations, Inc. Receives US FDA 510(k) Clearance for Mini-Rail Fixation System and Large Cannulated Screw System
NEW YORK--(BUSINESS WIRE)--Small Bone Innovations, Inc. (SBi), a leading, privately-held orthopedics company focused exclusively on technologies and treatments for the small bones & joints, announced that it has received 510(k) pre-market clearance notifications from the U.S. Food and Drug Administration (FDA) for Mini-Rail Fixation System (‘Mini-Rail System') and large Cannulated Screw System for use in lower limb reconstruction and repair procedures.
The Mini-Rail and Cannulated Screw systems further expand SBi's lower limb continuum of care product line.
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.*
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. The system's ease of use can decrease OR time. The Mini-Rail System was launched following a series of extensive evaluations by U.S. foot and ankle surgeons.
Guido LaPorta, DPM, FACFAS, Chief of Foot and Ankle Surgery at Community Medical Center, Scranton PA., said: "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."
SBi expects the large Cannulated Screw System, made out of stainless steel, 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: "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."
* Source: Ortho Fact book - Knowledge Enterprise, 2005
Guido LaPorta, DPM, FACFAS provides consulting services to SBi.
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi), founded in 2004 by Viscogliosi Brothers, LLC, (VB), the New York-based merchant banking firm specializing in musculoskeletal/orthopedics, is the first company to focus purely on small bones & joints. By integrating established companies and professionals in the field, SBi offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in small bones & joints. SBi has facilities in New York; Morrisville, PA; Bourg-en-Bresse, France; Donaueschingen, Germany and Kuala Lumpur, Malaysia.
For more information, please visit: www.totalsmallbone.com
Forward-looking statements
This news release contains forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of risks and uncertainties impacting SBi's business including increased competition; the ability of SBi to expand its operations and to attract and retain qualified professionals; technological obsolescence; general economic conditions; and other risks.