Synergy Biomedical, a privately held Wayne, Pennsylvania medical-device company, develops biomaterial bone-graft products for orthopedic and spinal surgery. Its BioSphere® technology uses spherical 45S5 bioactive-glass particles in a controlled bimodal size range, an approach the company developed to improve bone healing and distinguish its grafts from conventional irregular-particle materials. Synergy Biomedical is certified to ISO 13485 and operates a quality system aligned with FDA requirements.
ISO 13485
Omnia MedicalFounded by engineers and medical-device professionals, Morgantown, West Virginia-based Omnia Medical develops orthopedic implants for spine and interventional pain care. Its work is especially focused on sacroiliac-joint stabilization, including the PsiFGuard system, which the company describes as FDA-cleared real-time guidance technology for SI-joint detection. Omnia also develops spinal fusion and biologic solutions through surgeon collaboration, with a mission centered on safe, reproducible instrumentation and shorter operative times.MORGANTOWN, WV
Altus SpineAltus Spine develops and manufactures medical devices for spinal correction surgery, pairing surgeon collaboration with in-house engineering and manufacturing in its West Chester, Pennsylvania plant. Its systems include the Sochi occiput-to-sacrum platform and the Brickyard ALIF system, with design emphasis on streamlined instrumentation and rapid response to clinical needs. The company operates under ISO 13485 regulatory requirements and has received FDA 510(k) clearances for products including Sochi and Monaco HA.WEST CHESTER, PA
Globus MedicalBased in Audubon, Pennsylvania, Globus Medical develops and manufactures musculoskeletal technology for spine, orthopedic trauma and joint reconstruction procedures. Its work combines implants and biologics with enabling systems such as Excelsius™ robotic navigation, while its Musculoskeletal Education and Research Center supports surgeon training and multidisciplinary research. The company also applies advanced materials science to porous titanium and PEEK implants, and makes distinctive devices such as the magnetically adjustable Precice™ limb-lengthening system.AUDUBON, PA
OrthofixFounded in 1980, Orthofix is a Lewisville, Texas-based medical technology company that develops devices and biologic solutions for spine care and limb reconstruction. Its work spans reconstructive and regenerative treatment, including bone-growth therapies and the 7D FLASH Navigation System, with products used to help patients regain mobility in more than 60 countries. Orthofix also develops biologics through its in-house tissue bank in Irvine, California, and collaborations with MTF Biologics.WAYNE, PA