Orthopedic Implants

GOI is an orthopedic implants manufacturer specializing in producing trauma implants for hospitals, surgical distributors, and OEM partners across the United States, Mexico, and more than 40 other export markets. We are an ISO 13485-certified manufacturer, and we produce every implant in-house from titanium Ti-6Al-4V (ASTM F136) or 316L stainless steel (ASTM F138), the same material grades used across the orthopedic industry.

Because we manufacture rather than resell, hospital procurement teams and distributors buy directly from the factory that makes the product. That means factory pricing, direct access to our engineering team for OEM and private label work, and full traceability back to raw material heat numbers and mill certificates on request.

Our Orthopedic and Trauma Implants Family Overview

Trauma Plates: Locking and non-locking plates for internal fixation of long bone and periarticular fractures, machined from titanium Ti-6Al-4V or 316L stainless steel. Available in standard length and hole-count configurations, with mirror pair (left and right) options where the anatomy requires it.

Trauma Screws: Locking, Cortical, Cannulated, Cancellous, and speciality-based bone screws in self-tapping and self-drilling designs, produced in 2 mm length increments below 50 mm and 5 mm increments above 50 mm to match our plate systems for full construct compatibility.

Intramedullary Nails: Our intramedullary nail line is expanding. Current manufacturing capability covers femoral, tibial, and humeral nailing systems. If you need a specific diameter, length, or locking pattern, send your requirement to our technical sales team for a manufacturing quote.

External Fixation Systems: External fixation components, including pins, clamps, and frame hardware, are manufactured to OEM and distributor specification. Share your reference sample or drawing and our engineering team will confirm feasibility and lead time.

Specialty Fixation Systems: For periarticular, modular, and other complex fixation configurations outside our standard plate and nail lines, our engineering team works from your technical file or a competitor sample to produce a matching system.

A Factory-Direct Orthopedic Implants Supplier

Global Ortho Implants has manufactured orthopedic implants and surgical instruments for more than 20 years, exporting to hospitals, distributors, and OEM partners in over 40 countries. Our production facility operates under an ISO 13485 quality management system, and our implants are produced from certified titanium and stainless steel with full material traceability.

For hospital procurement teams, that traceability matters as much as price: every batch can be traced back to its raw material certificate. For distributors and OEM buyers, working with the manufacturer directly means shorter approval chains, private label options, and pricing without a reseller markup layered in.

Materials and Compliance

All GOI orthopedic implants are manufactured from titanium meeting ASTM F136, or 316L stainless steel meeting ASTM F138. Our quality management system is ISO 13485 certified, and full material and process documentation, including mill certificates and batch traceability records, is available to distributors and hospital procurement teams on request.

Global Ortho Implants supplies implants as a manufacturer to distributors and OEM partners. Local market clearance, such as FDA 510(k) registration in the United States or COFEPRIS registration in Mexico, is held by the importer or distributor of record in that market. We support this process with technical files, material certificates, and manufacturing documentation.

FAQs

What is an orthopedic trauma implant?
An orthopedic trauma implant is a surgical device used to stabilize broken bones during healing. Common types include locking plates, bone screws, intramedullary nails, and external fixators. GOI manufactures these in titanium and stainless steel for hospitals, distributors, and OEM buyers.

What materials does GOI use for orthopedic implants?
GOI manufactures implants from titanium Ti-6Al-4V meeting ASTM F136 and 316L stainless steel meeting ASTM F138, the two material standards most widely used in orthopedic trauma implants worldwide.

Can hospitals order orthopedic implants directly from Global Ortho Implants?
Yes. Global Ortho Implants works directly with hospital procurement departments, distributors, and OEM buyers. Orders are typically placed by wire transfer, and shipments to the US move via DHL Express or UPS on a Delivered Duty Paid (DDP) basis.

Does GOI manufacture custom or OEM orthopedic implants? Yes. We produce OEM and private label orthopedic implants against a customer’s technical drawing or reference sample, in addition to its standard catalog of locking plates, screws, nails, and fixation systems.

Is GOI an FDA approved or FDA registered manufacturer?
Global Ortho Implants is an ISO 13485 certified manufacturer that produces implants meeting ASTM F136 and ASTM F138 material standards. Market clearance for a specific country, including FDA 510(k) in the United States, is held by the importer or distributor of record, and GOI supports that process with technical documentation.

Does GOI ship orthopedic implants to Mexico?
Yes. Mexico is one of GOI’s primary export markets. Distributors handle COFEPRIS registration and local import requirements, and GOI provides the manufacturing documentation, material certificates, and technical files needed to support that registration.