Orthopedic trauma implants and instruments such as bone plates, screws, intramedullary nails, and their associated drills, drivers, and surgical guides play a critical role in fracture fixation and skeletal stabilization. These devices must perform reliably under significant physiological loads while maintaining tight dimensional tolerances and long-term biocompatibility.
As a contract manufacturing partner to global orthopedic OEMs, Sanbor Medical produces a broad portfolio of Class I and Class II orthopedic trauma devices, supporting customers from early production through full-scale commercialization. Our approach combines precision engineering, validated processes, and end-to-end documentation to meet the expectations of surgeons, regulators, and quality teams alike.
Manufacturing begins with certified implant-grade raw materials, including Stainless Steel 316LVM and Titanium Ti-6Al-4V ELI. Each material lot is supplied with a Certificate of Analysis (COA) verifying chemical composition and compliance with applicable ASTM and ISO material standards.
Upon receipt, our Quality team reviews and verifies all COAs to ensure full material traceability and conformity before production begins.
Orthopedic trauma components often involve complex geometries, tight tolerances, and critical interfaces. Machining is performed at qualified, ISO 13485–certified facilities using advanced multi-axis CNC equipment.
Process capability (Cpk) is routinely reviewed and audited to confirm consistent output and repeatability, particularly for load-bearing and fatigue-sensitive components.
Critical components undergo controlled heat treatment processes, such as solution annealing and aging, to achieve the required mechanical properties including tensile strength, hardness, and fatigue resistance.
Furnace processes are validated, and batch-level testing is performed to confirm conformance to specification before parts advance to finishing operations.
Deburring & Electropolishing
All components are carefully deburred and electropolished to produce smooth, corrosion-resistant surfaces. Electropolishing also removes microscopic surface contaminants, improving cleanability and biocompatibility.
Passivation (Stainless Steel Components)
Stainless steel parts undergo nitric acid passivation to reinforce the chromium oxide layer, enhancing corrosion resistance in physiological environments.
Laser Marking for Traceability
Each critical component is permanently laser-marked with a UDI, lot number, or part identifier, ensuring clear, durable traceability throughout the product lifecycle.
Before components are transferred to Sanbor Medical for final processing, suppliers provide a Certificate of Conformity (COC) confirming that all parts meet approved drawings, specifications, and process requirements.
Sanbor Medical operates a vertically integrated quality management system aligned with ISO 13485 quality and U.S. Food and Drug Administration 21 CFR Part 820, ensuring consistent compliance across every manufacturing stage.
First Article Inspections include 100% dimensional verification using CMMs and optical comparators. Additional sampling may include Rockwell hardness testing and corrosion resistance testing per ASTM International standards.
At critical control points, including post-machining, post-heat treatment, and post-surface finishing operators perform 100% visual and dimensional inspections, verifying compliance against approved samples and tolerances.
Prior to packaging, all instruments undergo validated cleaning processes, commonly including ultrasonic cleaning and deionized water rinses. Cleanliness testing verifies the absence of particulates and residual contaminants in accordance with validated methods.
Before release, finished devices undergo a final quality audit. Our Quality team compiles a complete Device History Record (DHR), including:
Raw material COAs
Supplier COCs
Inspection and test reports
Laser marking verification
Sterilization records (if applicable)
Final release Certificate of Conformity
This documentation package is reviewed for completeness and accuracy, supporting regulatory submissions for global authorities.
From certified raw materials to final packaged instruments, orthopedic trauma manufacturing is a disciplined process that demands precision, validation, and accountability at every step. By controlling each phase and documenting every detail, Sanbor Medical delivers orthopedic trauma implants and instruments that surgeons trust and that regulatory bodies approve with confidence.
Contact a Sanbor team member to learn more.