Pediatrics in Indiana

OrthoPediatrics Corp is a medical device manufacturer specializing exclusively in pediatric orthopedic products and solutions. Headquartered in Warsaw, Indiana, the company designs and manufactures implants, fixation devices, and surgical instrumentation specifically engineered for the unique anatomical and clinical needs of children and adolescents. Their product portfolio spans multiple pediatric orthopedic specialties including trauma management, deformity correction, external fixation systems, scoliosis treatment, sports medicine reconstruction (ACL and MPFL procedures), and post-operative care solutions. The company recently launched PediHip™ System for hip dysplasia treatment and management. OrthoPediatrics also operates KIDSenablingtech.com, an enabling technologies business division supporting the pediatric orthopedic field. The company emphasizes evidence-based, technology-driven approaches to pediatric orthopedic care, with products designed to improve surgical efficiency and patient outcomes. OrthoPediatrics serves pediatric orthopedic surgeons, surgical centers, and hospitals across multiple markets. The company provides clinical education and training to orthopedic surgeons and residents on innovative surgical techniques. Products are manufactured to meet high quality standards appropriate for pediatric applications, though specific regulatory certifications are not detailed in the available content.

Surestep, LLC is a pediatric orthotic manufacturer specializing in custom-made braces and orthotic devices for children from infancy through development. The company designs and fabricates ankle-foot orthoses (AFOs), supra-malleolar orthoses (SMOs), cranial remolding helmets, and related lower-extremity support devices. Their product portfolio includes conventional thermoplastic devices and advanced 3D-printed solutions, with recent product innovations including SMO3D (a lightweight, flexible 3D-printed SMO) and Sprout3D (a cranial remolding helmet with demonstrated clinical superiority in head-shape correction). Surestep emphasizes rapid manufacturing turnaround—AFOs in 10–14 business days, SMOs in 4–8 days depending on customization method, and Sprout3D in 7–10 days—enabling quick delivery to pediatric physical therapists, orthopedists, and rehabilitation centers. The company markets its devices for children with balance disorders, gait dysfunction, hypotonia, plagiocephaly, and other developmental orthopedic needs. All devices are custom-engineered for comfort and growth accommodation. Surestep maintains a clinical focus, citing peer-reviewed research (Hanger Institute study) demonstrating superior outcomes with 3D-printed cranial devices. The company serves pediatric rehabilitation, orthopedic, and developmental medicine markets across the US.

Trinity Guardion, Inc. manufactures the Soteria Bed Barrier, an FDA-cleared launderable protective barrier designed to protect hospital beds and mattresses from patient soiling and contamination. The product is engineered to reduce healthcare-acquired infections (HAIs) and meet FDA 2015 high-level disinfection standards (log 6 or 99.9999% kill of vegetative bacteria, mycobacteria, and spores) through a validated laundry process. Soteria is available in configurations for standard hospital beds (compatible with major manufacturers including Hill-Rom and Stryker) and for neonatal warmers and incubators (Panda Warmer and Giraffe Incubator models, patent-protected). Clinical studies demonstrate mattress pathogen reduction, approximately 10-minute time savings in room turnover compared to standard manufacturer instructions, and a 50% reduction in C. difficile transmission in long-term acute care settings. The company addresses a persistent industry challenge: contaminated hospital mattresses remain a known vector for HAI transmission despite emphasis from FDA, CDC, CMS, AMA, ECRI, and The Joint Commission. Soteria simplifies reprocessing by shifting disinfection-equivalent cleaning to the laundry cycle rather than requiring intensive chemical reprocessing during room turnover.