Bonevia Bonevia

Cannulated Screws Manufacturer & Factory serving United States

High-Precision Medical Implants Engineered to ISO 13485 & ASTM F136 Standards for US Healthcare Providers, Distributors, and ASC Networks.

The United States Orthopedic & Cannulated Screw Market

In the United States, the demand for orthopedic internal fixation devices continues to scale rapidly. The shift towards Minimally Invasive Surgery (MIS), coupled with the rapid growth of Ambulatory Surgery Centers (ASCs), has reshaped the purchasing criteria for orthopedic implants. Cannulated screws, which allow for percutaneous insertion over a guide wire, are now foundational in resolving femoral neck fractures, distal tibia fractures, and severe ankle-foot trauma.

However, US buyers—ranging from hospital purchasing groups (GPOs) to boutique distributors—face strict requirements. Products must adhere strictly to ASTM F136 ELI (Extra Low Interstitial) Titanium Alloy or ASTM F138 316L Stainless Steel specifications to ensure maximum fatigue limit, superior biocompatibility, and adequate torsional yield strength.

Key US Regulatory & Clinical Benchmark:

Bonevia's cannulated screws feature precise thread pitches (partially or fully threaded configurations), self-tapping and self-drilling tip profiles, and standardized star or hex drive sockets. These design criteria minimize surgical times while maximizing pull-out strength in osteoporotic bone—crucial metrics for US Joint Commission (TJC) accredited operating suites.

Bonevia Orthopedic Facility Cover Image

Bonevia Orthopedic Technology Co., Ltd.

Bridging Chinese Manufacturing Scale with US Market Compliance Since 2015

Established in 2015, Bonevia Orthopedic Technology Co., Ltd. has grown from a specialized manufacturer into a global medical supply partner. Operating a state-of-the-art facility optimized for high-precision machining, we generate an annual export revenue of USD 8–15 million. Supported by 6 years of export operations and over 10 years of domestic manufacturing experience, Bonevia is positioned to fulfill OEM, ODM, and contract manufacturing contracts for US clients.

85+ R&D Engineers
35+ QC Inspectors
120+ Annual New Designs
850+ Global Partners

Quality assurance is the core pillar of our manufacturing plant. Every production run undergoes a rigorous multi-stage verification framework: Incoming Material Inspection (X-ray spectroscopy verification of titanium grade), In-Process Statistical Process Control (SPC), and Final Product Tensile and Dimensional Testing. Managed by our 35 dedicated QC professionals, our testing lab guarantees that every screw shipped to North American shores conforms fully to clinical tolerances.

A Visual Guide to Our Precision Production Line

From raw medical titanium bars to sterile-ready orthopedic implants.

Medical Grade Raw Materials

1. Raw Material Sourcing

Imported medical-grade ASTM F136 Titanium Alloy rods and ISO 5832 stainless steel wire stocks.

Metal Slitting Process

2. Precision Slitting

High-speed cutting and bar feed preparation for dimensional uniformity across batches.

CNC Lathe Machining

3. CNC Primary Machining

Turning and primary shaft machining using advanced multi-axis CNC centers.

Thread Cutting & Cannulation

4. Deep-hole Cannulation

Precision gun-drilling processes creating concentric inner lumens for guide wire insertion.

Wire EDM cutting

5. Wire EDM Processing

Electro-discharge machining for high-tolerance surgical instrument interfaces.

Laser Etching UDI Markings

6. UDI Laser Marking

Clear, permanent laser marking for Unique Device Identification (UDI) compliance.

Class 10,000 Cleanroom Packing

7. QC Audit & Packaging

Microscopic evaluation followed by medical packaging ready for sterilization.

Controlled Temperature Warehouse

8. Storage & Logistics

Humidity and temperature-controlled storage keeping sterile integrity before transport.

Automatic Slitting Machinery

9. Automatic Feeders

Automated machinery feeding continuous alloy stock into the machining lines.

Swiss-type Lathe CNC Center

10. Swiss-type CNC Turning

Advanced lathes executing fine-threaded profiles on cannulated bone screws.

Manual Lathe Machine

11. Custom Tooling Lathes

Secondary metalwork and tool fabrication machines operating alongside CNC lines.

EDM Wire Cutting Equipment

12. Wire EDM Unit

Highly-calibrated wire cutting systems for micro-geometry screw designs.

Fiber Laser Engraver

13. Laser Marking Station

Fitted with clean-room extraction to prevent trace carbon surface contamination.

3D Modeling & Stress Simulation

14. Finite Element Design

Biomedical engineering staff utilizing FEA modeling to simulate implant stresses.

Optical Comparator Inspection

15. Metrology Inspection

Utilizing non-contact vision measurement systems to certify dimensional accuracy.

Biomechanical Engineering & Manufacturing Specifications

For cannulated bone screws, mechanical performance determines patient outcomes. During fracture compression, a screw is subjected to severe shear stress and cyclic loads. Bonevia implants are optimized to prevent two primary failure modes: guide wire binding during insertion and screw head shearing under compression.

Cannulation Concentricity

Any deviation in the runout of the inner cannulated pathway can result in the guide wire binding, or worse, splintering during surgical placement. By employing modern deep-hole gun drilling technologies under strict coolant pressure controls, Bonevia maintains a concentricity tolerance of within ±0.05 mm. This guarantees smooth advancement over standard Kirschner wires (K-wires).

Advanced Surface Passivation & Anodization

We apply Type II anodization to our medical-grade titanium alloy implants. This electrochemical process not only builds a bio-stable, inert oxide layer on the screw’s surface (preventing metal ion leaching into biological tissue) but also permits color-coding of screw diameters (e.g., 2.4mm, 3.0mm, 4.5mm, 6.5mm). This facilitates intraoperative organization in the sterile field.

Technical Innovation Roadmap

To support the next generation of patient care, our R&D roadmap focuses on:
1. Bio-absorbable Magnesium Alloys: Eliminating the need for secondary hardware removal operations.
2. PEEK Suture Anchors: Optimizing soft-tissue to bone repair structures for sports medicine clinics.
3. 3D-Printed Porous Titanium Interfaces: Encouraging rapid osseointegration on spinal and joint prosthetic surfaces.

Seamless Sourcing & Regulatory Compliance for US Buyers

Reducing logistics risks and ensuring product validation at the port of entry.

Navigating global supply chains requires reliable partners. Over the past 6 years, Bonevia has optimized its global distribution networks. We understand the requirements of US customs, including FDA import codes and shipping documentation, ensuring smooth clearance.

Our logistics workflow includes:

  • Material Certification: Providing physical mill test reports (MTR) verifying compliance with ASTM F136 or ASTM F138 for every production run.
  • Traceable Shipments: Standard packaging with barcode labels ready for warehousing.
  • Flexible Production Runs: Helping distributors manage inventory through tailored Minimum Order Quantities (MOQ).

Technical & Commercial FAQ

Answers to common regulatory, metallurgical, and sourcing questions.

Q1: What titanium grades do you use for cannulated screws shipped to the US?
We use medical-grade Ti-6Al-4V ELI (Extra Low Interstitial) conforming to ASTM F136 specifications. This grade offers high fatigue life, high corrosion resistance, and biocompatibility, making it the industry standard for implantable trauma devices in North America.
Q2: Do you support custom OEM/ODM designs for specialized orthopedic systems?
Yes, our engineering team of 85 specializes in OEM/ODM services. We work with client blueprints, SolidWorks models, or step files to produce custom thread designs, drive heads, and instrumentation kits. Last year alone, we introduced 120 new product designs for global partners.
Q3: What quality management system controls are utilized at your manufacturing facility?
Our quality management systems are certified to ISO 13485:2016. Every batch undergoes a series of QA gates managed by our 35-person QC department. Testing protocols include material composition analysis via spectrography, thread dimensional checks on optical comparators, and mechanical torque tests.
Q4: How do you prevent thread galling or driver slippage during surgical insertion?
We design our screws with optimized drive shapes, such as star or deep hex recess drives, which distribute rotational force evenly. Combined with automated CNC cutting that ensures sharp thread run-out, our design minimizes drive slippage and helps prevent insertion stalling.
Q5: What are your typical production lead times for standard cannulated screw sizes?
For standard sizes in stock, shipment can occur within 5-7 working days. For custom production runs or larger inventory restocks, lead times typically range from 45 to 60 days, depending on material availability and specifications.

Partner with an ISO 13485 Certified Implant Manufacturer

Secure your orthopedic supply chain with high-tolerance implants that meet standard clinical specifications. Reach out to our engineering team today.