Health Chi-Tech
Explore our premium, precision-engineered surgical devices built to meet rigid global regulatory standards.
Bone screws are not generic fasteners; they are structural implants that must survive extreme dynamic mechanical stress inside the human body. As a dedicated
We work exclusively with biocompatible materials that exhibit high fatigue strength and resistance to stress shielding. Our primary raw materials include Ti-6Al-4V ELI (Grade 23) and Ti-6Al-4V (Grade 5), conforming to ASTM F136 and ISO 5832-3 standards. This medical-grade titanium alloy offers an optimal strength-to-weight ratio, exceptional corrosion resistance, and excellent osteointegration capabilities.
Our engineering team works closely with medical brands to customize parameters such as thread pitches (cortical vs. cancellous), drive designs (hexagonal, star/torx, cruciform), and tip geometries (self-tapping, self-drilling) to minimize surgical insertion torque and maximize pullout strength.
From custom CNC Swiss-style sliding headstock machining to cleanroom chemical surface finishing, every stage of our production is optimized for ultimate surgical safety.
Using Swiss-type turning machines (Citizen, Star) with multi-axis capabilities to turn, mill, and thread bone screws in a single setup for absolute concentricity.
Implementation of cold thread rolling to optimize grain flow and increase fatigue strength, or custom thread whirling for complex variable-pitch designs.
Type II/III titanium anodization and citric/nitric acid passivation to construct a stable titanium oxide layer, preventing ion release and enabling color coding.
Multi-stage ultrasonic washing using pyrogen-free DI water. Vacuum-sealed sterile packaging under cleanroom protocols matching global standards.
Different clinical pathologies dictate varied thread profiles, lengths, and locking mechanisms. Our components are designed for targeted surgical environments.
Providing cortical, cancellous, and locking bone screws to stabilize long bone and small bone fractures. These screws integrate perfectly with anatomical compression plates to support immediate patient weight-bearing loading.
High-stability lumbar and cervical pedicle screws engineered with polyaxial and monoaxial heads. Designed to support transpedicular spinal fusion systems, correcting deformities and securing degenerative segments.
Interference screws engineered for anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstructions. Features custom round-head profiles to avoid soft tissue irritation and graft abrasion.
Customized micro-bone screws and plates optimized for feline, canine, and equine osteosynthesis. Engineered to resist dynamic mechanical stress in active companion and utility animals.
Combining 21 years of manufacturing experience, raw material traceabilities, and verified certifications (CE & ISO 13485) for premium biomedical supply chains.
Navigating the global medical device procurement process requires both rigid adherence to clinical specifications and strong commercial viability. Operating as a seasoned Chinese OEM manufacturer, we leverage a comprehensive regional supplier network to guarantee consistent material flow and reduced lead times.
Our localized infrastructure enables rapid scaling from custom design prototyping to high-volume manufacturing runs. We offer extensive customization scopes including
This localized cluster allows us to pass structural cost savings directly to global brand businesses, orthopedics distributors, and medical engineers in North America, South America, and European markets, without compromising on E-E-A-T principles or regulatory safety guidelines.
Visual validation of our multi-axis CNC Swiss machining, automated packaging, physical property testing labs, and high-tolerance quality inspection zones.
Medical devices are tightly regulated to protect patient safety. Every custom bone screw batch we produce conforms to international standards.
For custom bone screw manufacturers, regulatory compliance is the ultimate foundation of trust. In strict accordance with the Google Search Quality Rater Guidelines, we demonstrate our high-level expertise through verified compliance parameters:
Our manufacturing plant operates under ISO 13485:2016 certification (Registration Number: UKZB24MD30120R0S). This ensures that every process step—from design control, material procurement, cleanroom controls, and equipment calibration to final sterilization—is documented and auditable.
We possess multiple CE certificates (HD 60142131 0001 and G1 104715 0002 Rev. 01), confirming our compliance with the European Medical Devices Regulation (MDR 2017/745). This certification allows our clients to distribute our implants safely throughout EU member states and other global territories recognizing CE approval.
Every shipment is accompanied by Mill Test Reports (MTR) verifying the chemical composition and mechanical properties of our titanium raw materials. We strictly comply with ASTM F543 standards for mechanical performance, verifying the torsional yield strength, insertion torque, and pullout resistance of each design batch.
Everything you need to know about partnering with a leading medical-grade bone screw OEM manufacturer.
Complete your sourcing portfolio with our certified orthopedic kits, veterinary bone fixation implants, and surgical power tools.