SpiTrex Orthopedics grew from Mediliant, which began with a management buyout in 2014 and later expanded through partnerships and acquisitions in the United States and Europe. Today, it serves medical-device companies as a contract manufacturer focused on bringing orthopedic implants and instruments from concept through commercialization. Its global facilities are ISO 13485-certified and FDA registered.
ISO 13485:2016
certification
FDA Registration
registration
ISO 7 Clean Room
certification
Axial MedicalJust outside Philadelphia, Axial Medical is a dedicated contract manufacturer that takes medical implants from prototype through production, with a particular focus on complex spine and orthopedic work. Its 40,000-square-foot Warminster headquarters, custom-built in 2014, houses more than 60 five-axis CNC machines alongside in-house finishing and metrology capabilities. Axial Medical is ISO 13485:2016 certified and FDA registered.WARMINSTER, PA
TE OrthoTE Ortho grew from Tru-Edge’s cutting-tool regrinding work into a dedicated orthopedic instrument division more than 20 years ago, after customers asked whether the same precision could be applied to stainless-steel surgical parts. Today, it finish-grinds customer-supplied blanks for medical-device manufacturers, using validated processes designed to deliver consistent, burr-free results. The division holds ISO 13485:2016 and ISO 9001:2015 certifications.ST HENRY, OH
Infinite Medical SolutionsBuilt on more than 40 years of experience, Infinite Medical Solutions manufactures precision orthopedic and trauma implants and manages their engineering, processing, and assembly in Eastlake, Ohio. Its 200,000-square-foot facility on 14 acres is set up to scale complex medical-device projects, from spinal implant assemblies to micro-machined suture buttons. The company’s quality systems comply with ISO 9001, ISO 13485, and AS9100, reflecting its roots in aerospace as well as medical manufacturing.EASTLAKE, OH
Post Surgical Manufacturing IncFor more than 25 years, Post Surgical Manufacturing has made reusable orthopedic and other surgical instruments, taking projects from design through production as a single-source contract manufacturer. Its Hauppauge team combines experienced hand craftsmanship with design-for-manufacturability, precision machining, assembly and packaging, and can produce pilot or production runs as small as 25 parts. Post Surgical holds ISO 13485:2016 certification and has been recognized by Ethicon Endo-Surgery for quality and customer service.HAUPPAUGE, NY