OEM/ODM Cortical Screws Manufacturer & Factories

Precision-Engineered Orthopedic Trauma Fixation & Custom Implant Solutions Globally

Premium Orthopedic Implants & Systems

Explore our advanced clinical-grade fixation systems, engineered for anatomical compatibility and superior mechanical stability.

CANWELL Medical Titanium Plate for Skull Plate Fixation

CANWELL Medical Titanium Plate for Skull Plate Fixation Snow Flakes Interlink Plate Types of Orthopedic Plates Cranial Plate

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Fule Brand CE Certified Titanium Alloy Implant Set

Fule Brand CE Certified Orthopedic Surgery Titanium Alloy Implant Set Medical Plate Laminiplasty for Posterior Spine Surgery

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Orthopedic Surgical Instrument Micro Finger Bone Locking Plate Set

Orthopedic Surgical Instrument 1.5mm 2.0mm Micro Finger Palm Bone Locking Plate Trauma Surgery Instrument Set Stainless Steel

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CANWELL Clavicle Locking Plate Titanium Anterior Hook Reconstruction

CANWELL Clavicle Locking Plate Titanium Superior Anterior Hook Reconstruction Bone Orthopedic Implants Trauma Fracture Surgery

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Orthopedic Shoulder Joints Surgery Instrument Set Rotator Cuff Repair

Orthopedic Shoulder Joints Surgery Instrument Set Rotator Cuff Suture Hook Joint Ligament Repair Arthroscopy Instrument

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Orthopedic Upper Limbs Instrument Kit Small Fragment

Orthopedic Upper Limbs Instrument Kit Small Fragment Instruments Orthopedic Bone Instrument Set

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High Quality 5.0 Titanium Sliding Screw Pediatric Orthopedic Implants

High Quality 5.0 Titanium Sliding Screw Pediatric Orthopedic Surgery Spinal Screw-Rod System Implants CE Certified

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Geasure Stock Orthopedic Surgical Humeral Nail

Geasure Stock Orthopedic Surgical Humeral Nail for Osteoporotic Bone Fixation Medical Orthopedic

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Pioneering Clinical-Grade Osteosynthesis Technologies

As a premier global OEM/ODM cortical screws manufacturer, HBM Medical Apparatus And Instruments Co., Ltd. integrates advanced biomechanical engineering with state-of-the-art manufacturing to deliver high-performance fixation systems. Cortical screws play a pivotal role in orthopedic trauma surgery, requiring absolute precision in thread pitch, core diameter, and material biocompatibility to ensure optimal osseointegration and mechanical stability within dense cortical bone structures.

Our comprehensive production facility spans over 30,343 square meters, housing 12 highly automated production lines and more than 120 advanced CNC machining centers. With a dedicated R&D team consisting of 31 elite engineers, including postgraduates and doctoral experts, we provide tailored OEM/ODM solutions that comply strictly with ISO 13485, CE (MDR), and MDSAP standards.

  • Medical-grade Titanium Alloy (Ti-6Al-4V ELI) and Premium Stainless Steel (316LVM)
  • Swiss-type sliding head CNC lathes ensuring tolerances within ±0.005mm
  • Advanced surface treatments including Type II anodization and acid etching
30k+
Floor Space (㎡)
12
Production Lines
120+
CNC Machines
31
R&D Engineers

Macro Industry Solutions & Clinical Biomechanics

Addressing the complex mechanical demands of modern osteosynthesis through rigorous engineering and physiological alignment.

Stress Shielding Mitigation

By optimizing the thread profile and utilizing titanium alloys with a Young's modulus closer to human cortical bone, our screws minimize stress shielding, promoting healthy bone remodeling and faster patient recovery.

High Pull-Out Resistance

Our cortical screws feature a shallow thread depth and a fine pitch specifically designed to maximize contact area and purchase within the dense, hard structure of cortical bone, preventing mechanical failure under load.

Advanced Surface Topography

Through electrochemical anodization and micro-roughening, we enhance the surface energy of our implants, significantly accelerating osteoblast adhesion and long-term biological fixation.

Parameter Standard Specifications OEM/ODM Custom Range
Diameter Range 1.5mm, 2.0mm, 2.7mm, 3.5mm, 4.5mm 1.0mm to 6.5mm (Customized)
Material Grade Ti-6Al-4V ELI (ASTM F136), 316LVM Custom Alloys / PEEK / Biodegradable
Thread Type Self-Tapping / Self-Drilling / Standard Variable Pitch / Custom Lead Angle
Drive Interface Hexagonal / Star (Torx) / Cruciform Custom High-Torque Interfaces
Surface Finish Type II Anodized / Electropolished HA Coated / Acid-Etched / Color Coded

Global Commercial Scale & Supply Chain Resilience

The global demand for high-quality orthopedic trauma implants is rising rapidly, driven by aging demographics and increasing clinical expectations for immediate post-operative mobility. HBM Medical addresses this demand by maintaining a robust, vertically integrated supply chain. We source raw materials exclusively from certified medical-grade suppliers, ensuring complete traceability from raw titanium ingots to the final sterile-packaged screw.

With 10 years of exporting experience, our products are trusted across diverse global markets, including domestic clinical networks, Eastern Europe, and Southeast Asia. Our manufacturing infrastructure is optimized for high-volume production while maintaining the flexibility required for low-volume, highly specialized custom runs.

OEM/ODM Customization & Advanced Engineering

Transforming complex clinical concepts into high-precision, market-ready orthopedic solutions.

Sample & Graphic Processing

Provide us with physical samples, 2D drawings, or complex 3D CAD models. Our engineering team utilizes advanced software to optimize designs for manufacturability and clinical performance.

Rapid Prototyping

Accelerate your time-to-market. Our dedicated prototyping cell allows for rapid iteration of custom cortical screw designs, enabling functional testing and clinical evaluation in record time.

Customized Packaging & Labeling

We offer comprehensive private labeling solutions, including cleanroom sterile packaging (Class 100,000 / ISO Class 8) and custom-designed surgical kit configurations ready for clinical use.

Localisation Support & Global Regulatory Compliance

Navigating the complex regulatory landscape of medical devices requires a partner with deep expertise and robust quality systems. HBM Medical provides comprehensive regulatory support to facilitate local registration and market entry globally. Our quality management systems are certified to ISO 13485:2016 and comply fully with the Medical Device Single Audit Program (MDSAP).

Our cortical screws and orthopedic implants carry prestigious CE certifications (EPT 0477.MDR.25/5905 & EPT 0477.MDR.25/5973), ensuring compliance with the stringent European Medical Device Regulation (MDR). We assist our global partners by providing complete technical documentation, biocompatibility reports (ISO 10993), and sterilization validation data required by local health authorities.

  • Full regulatory dossier support (Technical Files, STED)
  • MDSAP certification covering USA, Canada, Japan, Australia, and Brazil
  • 36 dedicated QA/QC inspectors executing 100% inspection protocols
ISO
13485 Certified
CE
MDR Compliant
MDSAP
Global Audit Pass
100%
Raw Material Traceability

Clinical Application Scenarios & Systems

Engineered to perform in the most demanding surgical environments, from human trauma to advanced veterinary procedures.

Human Trauma & Reconstruction

Our cortical screws are widely utilized in standard plating systems for long bone fractures (femur, tibia, humerus, radius). They provide rigid internal fixation, ensuring anatomical alignment and immediate mechanical stability.

Posterior Spine Stabilization

Integrated within spinal screw-rod systems, our specialized cortical and pedicle screws offer high pull-out resistance in osteoporotic bone, facilitating successful lumbar and thoracic fusion procedures.

Veterinary Orthopedic Surgery

Designed for small animal fracture recovery, our micro-locking plates and TPLO/TTA systems utilize specialized cortical screws to support rapid bone healing in canine and feline orthopedic procedures.

Technical Roadmap & Future Outlook

Driving the next generation of osteosynthesis through smart materials and additive manufacturing.

Phase 1: Advanced Surface Modification

Implementing sub-micron bioactive coatings (such as Hydroxyapatite and Silicon-doped TCP) to accelerate osseointegration in compromised bone beds.

Phase 2: Biodegradable Magnesium Alloys

R&D focus on high-purity magnesium alloy cortical screws that gradually resorb in vivo, eliminating the need for secondary implant removal surgeries.

Phase 3: Smart Sensor Integration

Developing smart orthopedic implants with embedded micro-sensors to monitor real-time strain, temperature, and healing progress post-surgery.

Factory Tour & Advanced Manufacturing Facilities

Take a virtual tour of our 30,343 square meter state-of-the-art production facility, cleanrooms, and testing laboratories.

Frequently Asked Questions (FAQ)

Get authoritative answers to technical, regulatory, and commercial queries regarding our OEM/ODM cortical screw manufacturing.

What is the difference between cortical screws and cancellous screws?
Cortical screws are designed with a smaller pitch, shallower thread depth, and a larger core-to-outer diameter ratio. This configuration maximizes thread purchase and surface contact within dense, hard cortical bone. In contrast, cancellous screws feature a larger pitch and deeper threads to grip the softer, porous trabecular bone structure.
What materials are used in HBM cortical screws?
We primarily manufacture cortical screws using medical-grade Titanium Alloy (Ti-6Al-4V ELI conforming to ASTM F136 / ISO 5832-3) and Ultra-Clean Stainless Steel (316LVM conforming to ASTM F138 / ISO 5832-1). These materials offer exceptional biocompatibility, high fatigue strength, and excellent corrosion resistance.
What certifications do your manufacturing facilities hold?
Our facilities are certified under ISO 13485:2016 and ISO 14001. We have successfully passed the Medical Device Single Audit Program (MDSAP) under certificate C730178. Furthermore, our products hold CE MDR certifications (EPT 0477.MDR.25/5905 and EPT 0477.MDR.25/5973), allowing seamless distribution in highly regulated global markets.
Can you support custom OEM/ODM designs and private labeling?
Yes, we specialize in comprehensive OEM/ODM services. Our R&D team supports sample processing, graphic processing, and custom-on-demand engineering. We also provide sterile cleanroom packaging (Class 100,000) and custom laser marking for complete private labeling solutions.
How do you ensure the quality and traceability of the screws?
We maintain 100% traceability of all raw materials back to the original mill heat batch. Our quality control system involves 36 professional QA/QC inspectors executing rigorous in-process audits and 100% final dimensional inspections using advanced optical comparators and coordinate measuring machines (CMM).

Advanced Trauma & Surgical Instrumentation Systems

Explore our specialized surgical instruments, locking plates, and extraction kits engineered to streamline clinical workflows.

CANWELL Titanium Locking Plate Radius Plate

CANWELL Titanium Locking Plate Radius Plate 12 Distal Radius Dorsal Volar Wrist Orthopedic Trauma Implant Bone Fracture Class CE

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Medical Surgical Implant Removal Instrument Set Kit

Medical Surgical Surgucal Implant Removal Instrument Set Med Bolt Osteotome Tool Kit Broken Screw Remover of Orthopedic with Box

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Animal Tibial Surgery Veterinary Orthopedic Surgical TTA Rapid Cage

Animal Tibial Surgery Veterinary Orthopedic Surgical TTA Rapid Cage With Screws Cruciate Rupture Recovery Instrument Set

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Micro Mini Orthopedics Canulated Drill for Veterinary Surgery

Micro Mini Orthopedics Canulated Drill Surgery Operated Drill for Hand Wrist and Feet Veterinary Surgery Drill

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GEASURE TLIF PEEK Cage Lumbar Interbody Fusion

GEASURE TLIF PEEK Cage Lumbar Interbody Fusion for Spine Surgery Orthopaedic Implants CE Certified Class III

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Orthopedic Locking Plate Kit Veterinary Surgery Set

Orthopedic Locking Plate Instrument Small Animal Fracture Surgery Kit Tplo System Veterinary Basic Instrument Set

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Stainless Steel Cannulated Drill Bits Orthopedic Instrument

1pcs Stainless Steel AO Cannulated Drill Bits Hollow Drill Bits Autoclavable Orthopedic Instrument

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Bone Surgical Trauma Cannulated Screw Instrument Set

Hot Sales Bone Surgical Trauma Stainless Steel 3.5/4.0 mm Cannulated Screw Instrument Set

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