ISO 13485 & CE MDR Certified

Orthopedic Instrument Manufacturers & Supplier

Precision-Engineered Surgical Solutions, Advanced Implant Systems, and Global OEM/ODM Contract Manufacturing Excellence for Spinal and Trauma Reconstruction.

Product Portfolio

Premium Orthopedic Implants & Surgical Instruments

Explore our state-of-the-art spinal systems, custom titanium instrument sets, and minimally invasive surgical solutions engineered to deliver exceptional clinical outcomes.

Selftapping Polyaxial Titanium Pedicle Screw

Selftapping Polyaxial Titanium Pedicle Screw MIS Percutaneous Screw Tornillos Transpediculares Lumbar GB1Z-II 5.5-7.5

Technical Specifications
Custom-Made Surgical Medical Orthopedic Titanium Instrument Set

Custom-Made Surgical Medical Orthopedic Titanium Instrument Set Spinal Peek Cervical Implant TLIF Cage Bullet PLIF Electric

Technical Specifications
Geasure Spinal Surgery OLIF Instrument Set

Geasure Spinal Surgery OLIF Instrument Set OLLF Interbody Cage Instrument Set Surgical Instruments Basis

Technical Specifications
Geasure Orthopedic Implants Surgical Instruments Set

Geasure Orthopedic Implants Surgical Instruments Set Spinal Orthopedic System Medical Equipment for Interventional Materials

Technical Specifications
Geasure Orthopedic Medical Instruments Surgical Anterior Cervical Plate

Geasure Orthopedic Medical Instruments Surgical Anterior Cervical Plate Spinal Surgery Instrument Set

Technical Specifications
Geausre Titanium Mesh Cage Instrument Set

Geausre Titanium Mesh Cage Instrument Set Cervical Spine Implants for Interbody Fusion Bone Surgical Instruments

Technical Specifications
Geasure Competitive Price Orthopedic Surgical Instruments

Geasure Competitive Price Orthopedic Surgical Instruments Vertebral Body Shaping Pedicle Screws Instruments Set Class I 1 Year

Technical Specifications
Geasure Orthopedic Surgical Instruments Spinal Posterior Thoracic Pedicle Screw System

Geasure Orthopedic Surgical Instruments Spinal Posterior Thoracic Pedicle Screw System Thoracolumbar Plate System Class I 1 Year

Technical Specifications

30,343㎡

State-of-the-Art Factory Floor Space

350+

Advanced Processing & Testing Equipment

12+

High-Precision Production Lines

36

Dedicated QA/QC Inspectors

Corporate Overview

HBM Medical: Pioneering Orthopedic Manufacturing Excellence

HBM Medical Apparatus And Instruments Co., Ltd. is a leading orthopedic medical equipment R&D, manufacturing, and operation enterprise in China. With a sales network covering the entire domestic market and expanding rapidly across global regions, HBM has earned a stellar reputation for engineering superiority.

Equipped with first-class production machinery and backed by highly professional R&D, technology, and manufacturing teams, HBM operates under a quality management system strictly aligned with international standards. Our efficient marketing and service strategies ensure that we deliver unmatched value to our global partners, facilitating seamless integration and clinical success.

Our corporate philosophy—"Integrate the Master, Health being achieved"—drives our commitment to technological innovation, product refinement, and service excellence. By integrating superior global resources, we strive to serve the great cause of human health with unwavering dedication.

R&D and Technical Prowess

HBM Medical prioritizes a talent-driven growth strategy, building a highly qualified and innovative R&D team capable of solving complex mechanical and biological challenges in orthopedics.

  • 31 Professional R&D Engineers dedicated to continuous product innovation.
  • High Academic Profile: 1 Doctorate researcher, 11 Postgraduate specialists, and 17 Graduate engineers.
  • Rapid Prototyping: Over 25 new innovative products launched annually.
  • Customization Capabilities: Comprehensive sample processing, graphic processing, and customized on-demand engineering.
Supply Chain & Manufacturing

China Factory 4.0: Unmatched Supply Chain Resilience & Efficiency

How HBM Medical leverages advanced automation, raw material traceability, and industrial scale to guarantee consistent quality and cost advantages for global medical brands.

Advanced CNC Machining

Our facility houses over 120 high-precision production machines, including Swiss-type longitudinal CNC lathes, 5-axis machining centers, and wire-cut EDM systems. This allows us to achieve tolerances within ±0.005mm, essential for intricate spinal implants and complex trauma plates.

Full Raw Material Traceability

We enforce 100% traceability for all raw materials. Every batch of medical-grade titanium alloy (Ti-6Al-4V ELI), PEEK, and surgical stainless steel is sourced from certified global suppliers, accompanied by material test reports (MTR) and chemical composition analyses.

Rigorous Quality Control

With 36 professional QA/QC inspectors operating across all 12 production lines, we implement a multi-stage inspection protocol. This includes raw material verification, in-process inspection, coordinate measuring machine (CMM) dimensional verification, and 100% final visual and functional testing.

Innovation Roadmap

The Future of Orthopedic Instruments: Technology Roadmap

As surgical techniques evolve toward minimally invasive surgeries (MIS) and digital integration, HBM Medical is at the forefront of developing next-generation orthopedic solutions. Our technical roadmap focuses on three core pillars:

1. Smart & Navigated Surgical Instruments

Integrating electromagnetic and optical tracking arrays directly into our custom surgical instrument sets. This ensures seamless compatibility with leading surgical navigation and robotic systems, reducing fluoroscopy time and improving implant placement accuracy.

2. Advanced Surface Modification & Bio-PEEK

Developing advanced surface treatments, such as plasma-sprayed titanium coatings on PEEK cervical and lumbar cages, to enhance osteointegration while maintaining the radiolucent properties of PEEK implants.

3. Additive Manufacturing (3D Printing) Integration

Expanding our capabilities in 3D-printed porous titanium structures. By utilizing electron beam melting (EBM), we design and manufacture custom implants that mimic trabecular bone structure, facilitating rapid bone ingrowth.

Advanced Orthopedic R&D Lab

Sustainable Development & Scalability

Certified under ISO 14001 for environmental management, HBM Medical combines high-volume production capacity with sustainable manufacturing practices, ensuring long-term supply security for global medical device brands.

Clinical Applications

Comprehensive Macro Industry Solutions

From complex spinal reconstructions to high-volume trauma care, HBM Medical provides clinically proven systems designed to meet the rigorous demands of modern operating rooms.

Spinal Fusion & Fixation Systems

We offer complete solutions for spinal surgery, including anterior cervical plates, titanium mesh cages, PEEK lumbar cages (PLIF, TLIF, OLIF), and polyaxial pedicle screws. Our systems are engineered to restore sagittal balance and promote solid arthrodesis.

  • Self-tapping thread designs for optimal purchase
  • Bullet-nose cages for easy insertion
  • Low-profile plate designs to minimize dysphagia

Minimally Invasive Surgery (MIS)

Reducing patient trauma and accelerating recovery times are key drivers in modern orthopedics. Our MIS percutaneous screw systems and specialized spinal channel instruments allow surgeons to perform complex stabilizations through minimal incisions.

  • Extended-tab reduction screws
  • Ergonomic rod inserters and counter-torque drivers
  • Radiolucent retractor systems

Custom OEM/ODM Instrument Sets

Leveraging our 31-engineer R&D team, we partner with global medical device brands to design, prototype, and manufacture custom surgical instrument sets tailored to proprietary implant designs.

  • Medical-grade titanium and stainless steel
  • Custom silicone-molded handles for ergonomic grip
  • Laser etching and color-coded anodization
Global Regulatory Alignment

Uncompromised Quality: Certifications & Global Compliance

Navigating the complex regulatory landscape of medical devices requires a manufacturing partner with robust compliance credentials. HBM Medical is fully certified to support your market entry and expansion strategies globally.

CE

CE MDR Certified (EU 2017/745)

Our spinal implants and surgical instruments hold valid CE certificates (Cert No: EPT 0477.MDR.25/5905 & EPT 0477.MDR.25/5973), ensuring compliance with the latest European Medical Device Regulations.

MD

MDSAP Certified (Medical Device Single Audit Program)

Certified under MDSAP (Cert No: C730178), HBM Medical satisfies the stringent quality management system requirements of multiple global jurisdictions, including the USA, Canada, Australia, Japan, and Brazil, in a single audit.

ISO

ISO 13485:2016 & ISO 14001

Our entire 30,343 square meter manufacturing facility operates under the ISO 13485:2016 medical device quality management standard, guaranteeing absolute process control from design to delivery.

Global Procurement & OEM/ODM Framework

We provide a structured, transparent contract manufacturing framework designed to minimize risk and accelerate time-to-market for global medical device brands:

  • Phase 1: Design & Feasibility (DFM analysis, raw material selection, 3D CAD modeling)
  • Phase 2: Prototyping & Testing (Rapid CNC prototyping, mechanical fatigue testing, biocompatibility evaluation)
  • Phase 3: Regulatory Support (Technical documentation compilation, FDA 510(k) / CE MDR submission support)
  • Phase 4: Mass Production (Production in Class 100,000 cleanrooms, automated packaging, sterile barrier validation)
  • Phase 5: Logistics & Stocking (Flexible lead times, custom labeling, global distribution support)
Surgical Solutions

Advanced Spinal Fixation & Extraction Systems

Discover our specialized surgical instruments, cage delivery systems, and emergency extraction kits designed to ensure intraoperative flexibility and safety.

Geasure 5.5 mm Spine Pedicle Screw Instrument Set

Geasure 5.5 mm Spine Pedicle Screw Instrument Set Small Fragment Orthopedic Surgical Instruments for Fixation

Technical Specifications
Geasure Certificated Cervical Spine Instrument TLIF PEEK Cage Instrument Set

Geasure Certificated Cervical Spine Instrument TLIF PEEK Cage Instrument Set

Technical Specifications
Orthopedic Spine Surgery Cervical Cage Spinal Cervical Peek Cage Instrument Set

Orthopedic Spine Surgery Cervical Cage Spinal Cervical Peek Cage Instrument Set

Technical Specifications
Stainless Steel PLIF PEEK Lumbar Cage Titanium Lumbar Cage Instrument Set

Stainless Steel PLIF PEEK Lumbar Cage Titanium Lumbar Cage Instrument Set

Technical Specifications
Spinal Surgery Olif Spinal Fusion Cage Instrument Set

Spinal Surgery Olif Spinal Fusion Cage Instrument Set Peek Cage Surgical Instruments

Technical Specifications
Fast Delivery Orthopedic Instruments 5.5 Minimally Invasive Lumbar Spine Instrument Set

Fast Delivery Orthopedic Instruments 5.5 Minimally Invasive Lumbar Spine Instrument Set MIS Surgical Instruments Set

Technical Specifications
Competitive Price Surgical Instruments Spinal Channel Instrument Set

Competitive Price Surgical Instruments Spinal Channel Instrument Set Surgical Instruments Set Medical Instruments

Technical Specifications
Geasure Ortopedia Broken Screws Removed Instrument Set

Geasure Ortopedia Broken Screws Removed Instrument Set Screw Removable Instrument Set

Technical Specifications
Inside HBM Medical

Advanced Production Facility & Cleanrooms

A visual tour of our 30,343 square meter manufacturing facility, showcasing our high-precision machining, cleanrooms, and testing laboratories.

FAQ

Frequently Asked Questions & Sourcing Insights

Get professional answers to key questions regarding orthopedic instrument manufacturing, material selection, regulatory compliance, and custom OEM/ODM partnerships.

What materials are primarily used in HBM's orthopedic implants and instruments? +
We utilize premium medical-grade materials that guarantee biocompatibility, high fatigue strength, and corrosion resistance. For implants (such as pedicle screws and mesh cages), we primarily use Titanium Alloy (Ti-6Al-4V ELI) and Polyetheretherketone (PEEK). For surgical instruments, we use high-grade surgical stainless steels (such as 17-4 PH, 420, and 304) to ensure edge retention, durability, and resistance to repeated autoclave sterilization cycles.
How does HBM Medical support the regulatory registration process for global buyers? +
HBM Medical provides comprehensive regulatory documentation support. Since we are certified under MDSAP (Medical Device Single Audit Program) and hold multiple CE MDR certificates, we can supply complete technical dossiers, biocompatibility reports, mechanical testing data (ASTM standards), and sterilization validation files. This significantly accelerates the registration process with the FDA, EMA, and other local health authorities.
Can HBM manufacture custom surgical instrument sets for proprietary implant systems? +
Yes, custom OEM/ODM manufacturing is one of our core strengths. Backed by our 31-engineer R&D team and over 120 advanced CNC machines, we can design and manufacture bespoke surgical instrument sets tailored to your specific implant dimensions. We offer full customization, including ergonomic silicone handles, custom laser marking, color-coded anodization, and custom-designed sterilization trays.
What quality control measures are implemented during the production process? +
We implement a rigorous multi-tier quality control system managed by 36 dedicated QA/QC inspectors. This includes 100% raw material inspection (with spectral analysis), in-process dimensional checks on CNC lines, coordinate measuring machine (CMM) verification for complex geometries, and 100% final visual and functional inspection. All processes are fully traceable under our ISO 13485:2016 certified quality management system.
How does HBM ensure the cleanliness and sterility of its orthopedic products? +
All implants and critical instruments undergo final cleaning and packaging in our state-of-the-art Class 100,000 (ISO Class 8) cleanrooms. We utilize automated multi-stage ultrasonic cleaning systems with purified water to eliminate particulate and organic residues. Products can be supplied non-sterile (for hospital sterilization) or sterile-packaged (validated gamma or EO sterilization) based on client requirements.
What is the typical lead time for custom OEM orders? +
For standard products or existing designs, lead times typically range from 30 to 45 days. For custom OEM/ODM projects, the timeline depends on the complexity of the design. Typically, CAD design and DFM analysis take 1-2 weeks, prototyping and initial testing take 3-4 weeks, and mass production begins immediately upon prototype approval, taking approximately 45-60 days.
All Orthopedic Instrument Products