Dienen, Inc

Surestep LLC, based in South Bend, IN, is a leading provider of custom-made orthotic solutions for children with mobility challenges, particularly those with pronation or low muscle tone hypotonia. Their patented Surestep SMO system has revolutionized orthotic management worldwide, offering stability and independence to children as they run, jump, and play. With a comprehensive product line tailored to each child's specific needs, Surestep aims to build strength, confidence, and independence in every child who wears their orthoses. Loved by parents, orthotists, and physical therapists, Surestep is dedicated to providing life-changing solutions that help children move with comfort and ease.Generated from the website

History of OrthoPediatricsThe concept for OrthoPediatrics originated in the mid 1980's by Nick Deeter as a business idea to provide better splinting and bracing for orthopedic problems in children. Because of the highly competitive nature and low margins, the business never materialized. During the period between the mid 1980's and the formalization of OrthoPediatrics, Mr. Deeter continuously monitored the pediatric orthopedic industry. He felt that because the trend for implantable devices in adults was becoming the norm, healthcare providers would eventually move toward some of the same philosophies in children.Beyond the trend to use implantable hardware rather than casting and bracing in children, the last decade has given way to regulatory reform enabling pediatric orthopedic products a high priority path through the FDA. The declaration of the Juvenile Arthritis as a National Healthcare Priority in a bill signed by President Clinton in October, 2000, the Medical Devices Technical Corrections Act of 2004, and the Pediatric Medical Device Safety and Improvement Act of 2007 have helped remove some of the barriers to increase the availability of devices for the treatment of conditions affecting children, thus allowing OrthoPediatrics the opportunity to effectively and exclusively focus on this small niche within the orthopedics industry.The current state of the pediatric orthopedic market is one of unmet needs and frustration among caregivers. Science suggests implantable devices are the best treatment for many conditions. However, regulatory agency barriers are just now reforming enough to allow reasonable economic entry for device manufacturers into the pediatric market. The pediatric market is much smaller than the $28 billion world-wide adult orthopedic market ; hence all the established orthopedic manufacturers are not interested in serving what was a $400 million US market in 2006.OrthoPediatrics was formally established in 2006 when Mr. Deeter formed a business team of orthopedic experts in engineering, marketing, regulatory, finance and manufacturing from Warsaw, Indiana, the "Orthopedic Capital of the World" and home to industry giants like Zimmer, Biomet and Johnson & Johnson's DePuy Orthopaedics. In order to ensure the clinical success of the devices, Mr. Deeter requested the help of many elite pediatric orthopedic surgeons from around the country. Together, the business team and surgeon experts are inventing and designing superior orthopedic implants for children.Mr. Deeter's extensive background in orthopedics and technology transfer, coupled with his company start-up skills and global surgeon contacts brings the OrthoPediatrics concept to life as "The Smallest Company in Orthopedics ".