Bonevia Bonevia

OEM/ODM Bone Plates & Screws Manufacturer & Supplier

Precision-Engineered Trauma Fixation Systems & Joint Reconstruction Implants Conforming to Strict FDA & CE MDR Standards

Bonevia Orthopedic Technology Co., Ltd.

Bonevia Orthopedic Technology Co., Ltd. is a clinical-driven professional manufacturer specializing in orthopedic implants, surgical instrumentation, and custom trauma solutions. We are dedicated to advancing surgical innovation across global healthcare networks, providing specialized solutions for trauma fixation, spinal fusion, joint reconstruction, and sports medicine.

Established in 2015, Bonevia has transitioned into a key strategic manufacturing partner for medical device brands, GPOs, hospital systems, and global distributors. Equipped with a modern fabrication center, our production facility features a specialized 320㎡ high-efficiency floor space optimized for high-precision CNC multi-axis milling, wire EDM cutting, and sterile packing. Through direct vertical integration and efficient processes, we secure an annual export revenue of USD 8–15 million, backed by over 10 years of domestic medical sector expertise and 6 years of export trade experience across high-compliance markets.

  • Material Traceability: Every batch utilizes certified medical-grade raw materials (Titanium Alloy Ti-6Al-4V ELI, Cobalt-Chromium, 316L Stainless Steel).
  • Advanced R&D Pipeline: Managed by 85 R&D engineers, launching 120 new products/designs annually.
  • Comprehensive OEM/ODM Framework: Supporting custom sizing, private labeling, custom instrument kits, and regulatory filing support.
Bonevia Orthopedic Plant Facility

Our Operational Footprint at a Glance

A robust supply infrastructure engineered for quality stability and on-time global logistics.

8-15M
USD Annual Revenue
Backed by high-volume global surgical supply contracts
85+
R&D Engineers
Continuous design iteration, CAD modeling, and FEA testing
35
QC Inspectors
100% rigorous validation protocols for chemical and mechanical integrity
850+
Ecosystem Partners
Secure supply of raw materials and surface treatment facilities

Engineering & Material Integrity of Bone Plates & Screws

Ensuring optimal osteosynthesis through clinical design, metallurgy controls, and biomechanical parameters.

Advanced Medical Metallurgy

We source medical-grade Titanium Alloy (Ti-6Al-4V ELI / ASTM F136) and Stainless Steel (316LVM / ASTM F138) to guarantee biocompatibility. Our alloys feature low interstitial elements (ELI) for enhanced fracture toughness and superior fatigue resistance under variable loads.

Precision Anodization

Applying electrochemical surface modifications, including Type II and Type III titanium anodization. This creates a bio-inert oxide layer that minimizes ion leakage, increases wear resistance, and allows for color-coding of screw diameters for swift surgical identification.

Dynamic Dynamic Compression

Our plate geometries incorporate specialized combination dynamic compression holes (Combi-Holes). They give surgeons the option to compress bone fragments statically using standard cortical screws or stabilize them angularly using locking screws within a single construct.

Our Full-Cycle OEM/ODM Customization Program

From medical CAD designs to regulatory-ready packaging, we translate clinical concepts into market-ready implants.

Surgeon-Driven Design & FEA Prototyping

Our engineering team works closely with consulting orthopedic surgeons and bioengineers. Using 3D computer modeling, we execute detailed Finite Element Analysis (FEA). This process simulates implant performance, predicts stress-shielding regions, and optimizes structural profiles before manufacturing prototypes.

Custom Instruments & Structural Set Integration

Our OEM/ODM solutions extend beyond single implants. We develop complete surgical instrument sets, including drill guides, customized aiming devices, depth gauges, torque limiters, and trials. This ensures the implants pair correctly with their corresponding instruments during surgery.

Bespoke Osteotomy & Anatomical Contouring

Leveraging patient-specific CT datasets, we design anatomically pre-contoured plates. This reduces the need for intraoperative plate bending, preserves the periosteum, and decreases OR time. These designs are highly beneficial in complex reconstructive procedures and pediatric osteotomies.

UDI Compliance & Cleanroom Sterile Packaging

We provide medical devices that comply with FDA Unique Device Identification (UDI) regulations, featuring durable laser-etched matrix barcodes. Implants are packaged in ISO Class 7 cleanrooms using validated thermoformed blister trays, maintaining high sterility assurance levels (SAL 10^-6).

Factory Tour: Traceable In-House Manufacturing Process

Every step in our fabrication facility is monitored by a team of 35 QC specialists, ensuring complete material traceability.

Raw Materials Inspection
1. Materials Selection

Incoming verification of titanium bars & plates using spectral analysis to ensure correct chemical composition.

Slitting Machine
2. Slitting Machine Prep

Heavy-duty slitting and sectioning of medical alloy rods to exact sizes for the machining queue.

Slitting Process
3. Slitting and Sizing

Precise slicing of plate profile blocks, maintaining material integrity and avoiding structural micro-fractures.

CNC Machining Center
4. CNC Machining Center

Multi-axis milling machines carving anatomically contoured bone plate shapes with micro-millimeter precision.

Lathe Processing
5. Lathe Operations

Ultra-precise lathe turning of orthopedic locking and cortical screw threads, ensuring consistent thread pitch.

Machining Phase
6. Component Machining

Machining bone plate surfaces to achieve a smooth finish, reducing dynamic stress points.

Second Machining Step
7. Refining and Deburring

Secondary machining and deburring stages to smooth plate edges and prevent vascular tissue irritation.

Wire-cutting Machine
8. Wire-cutting EDM Machine

High-precision electrical discharge wire-cut machines forming complex locking tab features.

Wire-cutting Process
9. Profiling & Slots

Executing thin structural slots and surgical pathways for specialized reconstruction designs.

Laser Marking Machine
10. Laser Marking Unit

Automated fiber laser system etching UDI barcodes and batch numbers directly onto implants.

Laser Marking Application
11. UDI and Scale Marking

Durable markings ensure visibility during revision surgeries and maintain clear records for tracing.

Design Verification
12. CAD Design Review

Cross-referencing finished batches with initial design parameters using advanced CAD modeling tools.

Inspection and Packing
13. Inspection & Packing

Dimensional and micro-crack inspections, followed by cleanroom packaging in double-barrier peelable pouches.

Warehouse and Logistics
14. Temperature-Controlled Warehouse

Secure holding bay for sterilized batches, ready for logistics dispatch and immediate worldwide shipping.

Supply Chain Strengths & Compliance Assurance

How our manufacturing infrastructure helps global distributors reduce operational risks and manage procurement costs.

China's Supply Chain Advantages

Bonevia leverages its location in China's advanced medical manufacturing hubs. This provides access to certified titanium suppliers, heat-treatment facilities, and specialized surface treatment plants. Proximity to these resources allows us to offer cost-competitive manufacturing while meeting international quality standards.

Strict Verification (IQ/OQ/PQ)

We apply rigorous verification protocols (Installation, Operational, and Performance Qualification) to all CNC tools and processes. Our engineering teams perform automated CMM coordinate inspection, optical microscopy profile analysis, and routine mechanical testing, including torque and pull-out tests.

Regulatory Document Support

We assist our partners with local health registrations, including FDA 510(k), CE MDR Class III, and country-specific filings. We provide complete technical files, biocompatibility reports (ISO 10993), sterilization validation data (ISO 11137), and raw material certificates to support compliance.

Localized Application Scenarios

Supporting diverse orthopedic applications, from specialized human trauma surgeries to veterinary procedures.

Human Trauma and Osteosynthesis

Our dynamic locking plates and cannulated screws are used in trauma surgery to treat proximal femur fractures, distal radius fractures, and clavicle breaks. They provide the necessary stability to facilitate primary bone healing and early patient mobilization.

Veterinary Orthopedics

We manufacture a specialized line of micro-locking plates, distal femoral plates, and surgical saws for small animal procedures. These systems are designed to fit the unique anatomy of dogs, cats, and small animals, supporting veterinary clinics worldwide.

Reconstructive Sports Medicine

Providing specialized solutions like aiming guides and reconstruction devices for AC joint repairs and ligament reconstruction. These products help restore natural biomechanics and promote tendon-to-bone integration in active patients.

Industry Trends in Orthopedic Fixation (2024–2030)

Key advancements shaping the design and manufacturing of modern orthopedic implants.

Bioresorbable Magnesium Implants

The industry is transitioning toward biodegradable alloys (like magnesium and zinc) for temporary fixation. These materials slowly dissolve as the bone heals, eliminating the need for a second surgery to remove the hardware and reducing long-term clinical risks.

3D-Printed Porous Titanium

Additive manufacturing enables the production of porous titanium mesh structures. These structures mimic the mechanical properties of trabecular bone, helping to prevent stress shielding and encouraging direct bone ingrowth for long-term stability.

Antibacterial Surface Treatments

To reduce the risk of implant-associated infections, manufacturers are developing active surface coatings, such as silver nanoparticles and copper-infused oxide layers. These coatings inhibit bacterial colonization without affecting osseointegration.

Frequently Asked Questions

Answers to technical, regulatory, and logistics questions commonly asked by our procurement partners.

What is the difference between locking bone plates and dynamic compression plates (DCP)?
Locking bone plates thread the screw directly into the plate, creating a fixed-angle construct that does not rely on plate-to-bone friction. This design helps preserve the periosteal blood supply and is beneficial in osteopenic bone. In contrast, Dynamic Compression Plates (DCP) rely on the screw head pressing the plate against the bone, using friction to stabilize the fracture and allowing for compression across the fracture line.
Which titanium grades are used in orthopedic screws and plates?
We primarily use Titanium Grade 5 ELI (Ti-6Al-4V Extra Low Interstitials) conforming to ASTM F136 standards. Grade 5 ELI offers improved ductility and fracture toughness compared to standard industrial titanium, making it suitable for long-term load-bearing implants.
How does Bonevia support OEM/ODM clients with international regulatory compliance?
We provide a complete documentation package for regulatory submissions, including raw material traceability certificates, ISO 13485 quality records, manufacturing validation files (IQ/OQ/PQ), and biomechanical test reports. Our engineering team assists partners in aligning these files with FDA, CE MDR, and other regional regulatory requirements.
What is the typical lead time for custom OEM bone plate orders?
Lead times depend on design complexity. Standard modifications or custom sizing typically take 4–6 weeks for prototyping and validation, followed by 6–8 weeks for volume production. Complete new designs requiring custom molds or unique tooling may require additional development time.