Blutree Orthopedic Implants Blutree Orthopedic Implants

Global OEM/ODM Neurostimulators Supplier & Exporters

Pioneering High-Precision Neuromodulation, Active Implantable Medical Devices (AIMD), and Advanced Biocompatible Orthopedic Solutions Since 1999

Premium Implantable Systems & Components

Engineered to strict clinical quality parameters, satisfying international safety regulations for active implantable and orthopedic treatments.

Orthopedic Implants Titanium Medical Bone Screws
Orthopedic Implants Titanium Medical Bone Screws Cannulated Headless Compression Screw
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Orthopedic Plates Titanium Medical Surgical Fracture Bone Trauma
Orthopedic Plates Titanium Medical Surgical Fracture Bone Trauma Large Fragment Proximal Femur Neck Plate with Hook Locking Plate with CE
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Geb111 Replacement Battery
Geb111 Replacement Battery for Total Station Surveying
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Multi-Ring Combined Fixator
Multi-Ring Combined Fixator, Cobra External Fixator
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Proximal Lateral Tibia Locking Plate
Hot Saling Proximal Lateral Tibia Locking Plate, Bone Plate, Orthopedic Implant
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Orthopedic External Fixation Mini Fixator
Orthopedic External Fixation Mini Fixator
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Innovative Shoulder Abduction Bracket
Innovative Shoulder Abduction Bracket for Improved Range of Motion and Have OEM
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Trauma Fixation Implants Skull Fracture Surgery
Trauma Fixation Implants Skull Fracture Surgery Titanium Surgical Bone Locking Screw Orthopedic Straight Reconstruction Mini Cranial Maxillofacial Plate
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About Our Manufacturing Legacy

Founded in 1999, our enterprise stands as one of the pioneer organizations in China committed to the research, development, and high-precision production of implantable orthopedic devices and micro-medical structures. Over the last two decades, we have continuously translated complex biomechanical principles into world-class implant systems.

By leveraging our deep-seated proficiency in titanium micro-milling, biocompatible coatings, and cleanroom assembly, we have transitioned our state-of-the-art capability into the design and production of Neurostimulators (Active Implantable Medical Devices - AIMD). We work closely with clinical developers, academic partners, and global medical device OEMs to engineer neuromodulation devices that address chronic pain, movement disorders, and therapeutic neural interfaces.

Hemodialysis, Critical Care, Percutaneous Coronary Intervention PCI capabilities
1999
Established Year
160+
Sales Countries & Regions
60+
Local Registrations Obtained
3+
Overseas Offices (US, NL)
100+
Global OEM Partners
214
Products Officially CE Certified

The Macro Landscape of Implantable Neurostimulation

How medical science and micro-manufacturing converge to deliver next-generation therapeutic intervention.

Macro Industry Solutions

Neuromodulation has transitioned from a last-resort intervention to a cornerstone therapy for chronic conditions. Neurostimulators modulate electrical signals in central, peripheral, or autonomic neural pathways to manage:

  • Spinal Cord Stimulation (SCS): Providing relief for complex regional pain syndrome (CRPS) and failed back surgery syndrome.
  • Deep Brain Stimulation (DBS): Modifying motor patterns to treat Parkinson’s disease and essential tremors.
  • Vagus Nerve Stimulation (VNS): Offering alternative therapy for drug-resistant epilepsy and severe depression.
  • Sacral Nerve Stimulation (SNS): Addressing severe pelvic floor and bladder dysfunctions.

OEM/ODM Partnership Model

Developing an active implantable device from scratch demands multi-disciplinary expertise. As a contract manufacturer, we provide turnkey solutions:

  • Hermetic Packaging & Feedthroughs: Ensuring 100% barrier isolation to protect micro-electronics from body fluids.
  • Bio-Compatible Surface Treatments: Sputtered platinum-iridium or titanium nitride coatings to optimize charge delivery.
  • Surgical Lead Integration: Interfacing stimulation electrodes with highly flexible, fatigue-resistant lead lines.
  • Co-Development of Batteries: Leveraging custom battery solutions (like our specialized medical power configurations) for longevity.

Compliance & Quality Systems

Active implants fall under the highest regulatory classification globally (Class III FDA/MDR). Our ISO 13485 facilities feature:

  • Traceable Component Sourcing: Every screw, battery element, and titanium plate is mapped from medical-grade raw ingots.
  • Class 10,000 Cleanroom Operations: Minimizing bioburden and particulate contamination during assembly.
  • Design Dossier Support: Extensive testing metrics to accelerate your FDA 510(k), PMA, or CE MDR submissions.
  • Physical Testing Protocols: Full tensile, compression, and hermeticity verification assays.

Technological Infrastructure & Production Capability

Our in-house capabilities span raw titanium machining to high-level micro-structural finishes, ensuring optimal clinical performance.

LEPU Medical Collaboration

Core Fabrication Processes

CNC Machining
CNC Machining
High-precision milling of housing structures and micro-sized implant screws.
Tumbling
Tumbling
Mechanical deburring to remove surface irregularities on metallic plates.
Polishing
Polishing
Enhancing surface smoothness to reduce friction and tissue irritation.
Washing
Washing
Ultrasonic cleanroom washing protocols targeting particle-free output.
Quality Checking
Quality Checking
Rigorous optical and dimensional verification of all critical tolerances.
Packing
Packing
Double barrier sterile packaging under ISO Class 5 and 7 environments.

State-of-the-Art Machining & Inspection Centers

Wire Cutting Machine
Wire Cutting Machine
Wire electrical discharge machining (EDM) for intricate custom geometry.
Slitting Machine
Slitting Machine
High-accuracy slicing and material preparation for thin-walled foils and tubes.
CNC Machining Center
CNC Machining Center
Simultaneous multi-axis machining centers facilitating high yield outputs.
Tumbling Machine
Tumbling Machine
Centrifugal and vibratory surface finish machines for complex batch cycles.
Pressure testing machine
Pressure testing machine
Validating internal seals against high environmental pressure limits.
Durable testing machine
Cyclic fatigue and lifetime profiling for orthopedic implants and casings.
Tensile testing machine
Tensile testing machine
Determining mechanical limits, breaking points, and load-bearing capacities of biocompatible metals and cables.
Secondary Mechanical Inspection

Technical Roadmap & Future Outlook

As the neuromodulation market shifts toward personalized, closed-loop solutions, we are investing heavily in technologies that define the next decade of therapeutic delivery:

1. Miniaturization & Flex-PCB Integration

By integrating ultra-compact multi-layer flexible print circuit boards (Flex-PCBs) inside hermetically-sealed micro-titanium cases, we aim to reduce overall device volume by up to 35%, facilitating minimally invasive patient implantation procedures.

2. Closed-Loop Physiological Sensing

Future implant architectures will incorporate local field potential (LFP) feedback. The stimulator dynamically adapts stimulation parameters based on real-time neural activity, reducing battery draw and avoiding target habituation.

3. High-Density Electrodes & Advanced Sputtered Coatings

Using specialized vacuum magnetron sputtering system configurations, we apply ultra-thin films of Platinum-Iridium (Pt-Ir) and Iridium Oxide (IrOx) to maximize charge injection capacity, ensuring safe stimulation at smaller electrode footprints.

Local Compliance & Global Support Networks

Operating as a premier global OEM exporter involves navigating a complex web of national health mandates and manufacturing protocols. We ensure absolute compliance at every phase:

  • Regulatory Documentation: Providing localized regulatory filing support in over 60 countries and regions. Our technical documentation includes comprehensive biocompatibility dossiers (ISO 10993) and sterilization validation reports.
  • Localized Logistics & Warehousing: With strategic offices in the United States and the Netherlands, we coordinate directly with local distributors to manage shipping lanes, duty clearances, and import compliance documentation.
  • On-Site Technical Auditing: We extend auditing privileges to global buyers, facilitating virtual or physical cleanroom verification visits to meet validation protocols (IQ/OQ/PQ).

Industry Q&A: OEM/ODM Neurostimulation

Addressing technical, material, and regulatory inquiries from design engineers and procurement officers.

Q1: What materials are utilized for the hermetic containment of your neurostimulators?
Our hermetic housings are constructed using biocompatible, medical-grade Titanium (Grade 1 or Grade 5 Ti-6Al-4V ELI) to guarantee long-term stability and high resistance to bodily fluids. For critical feedthrough ports, sapphire or ceramic-to-metal brazing techniques are employed to maintain hermetic seal integrity.
Q2: Can you assist with global regulatory filings for custom ODM neuromodulation products?
Yes. With 214 products CE certified and registrations in 60+ countries, our regulatory affairs team provides complete Technical File access, design history file (DHF) records, validation logs (ISO 13485), and clinical trial support documentation to facilitate FDA, MDR, or national registrations.
Q3: What are the typical lead times and MOQ for contract manufacturing services?
MOQ is based on design complexity and testing specifications. Custom prototyping cycles typically run 8-12 weeks, followed by pilot production phases. Serial manufacture timelines range from 6 to 12 weeks, depending on component availability and scheduling of sterile packaging operations.
Q4: How do you perform hermeticity and seal validations?
Each sealed enclosure undergoes Helium Leak Detection testing in accordance with MIL-STD-883. We verify leak rates down to less than 1x10^-8 atm cc/sec, ensuring moisture protection for the internal control logic and battery packages over a projected 10-year implant lifespan.

Specialized Surgical Systems & Hardware

Complementary surgical toolsets, specialized fasteners, and equipment engineered to support complex orthopedic and neuromodulation therapies.

Discounted Price Titanium Coating Surgical Instrument Set
Discounted Price Titanium Coating Surgical Instrument Set Orthopedic Implant Olif Lumbar Interbody Fusion Peek Cage System
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Endblock for Vacuum Magnetron Sputtering Coating System
Endblock for Vacuum Magnetron Sputtering Coating System Vacuum Plating
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CE Certified Orthopedic Pelvic Reconstruction Plate Instrument Set
CE Certified Orthopedic Pelvic Reconstruction Plate Instrument Set for Hip Reconstruction
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Galvanized Pin Stud Screw
DIN/ANSI/BS/JIS Carbon-Steel/Stainless-Steel 4.8/8.8/10.9 Galvanized Pin Stud Screw for Building Railway
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Disposable Surgical Instrument Vertebroplasty System
Disposable Surgical Neulen Laminoplasty Inter Pedicle Screw Orthopaedic Instrument Expandable Cage Implant Apex-L B-4.2-3 Dilator Assembly Vertebroplasty System
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Nx Medical Orthopedic Cannulated Compression Screw
Nx Medical Orthopedic Implant Cannulated Conical Headless Compression Screw - II Metallic
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ACL Surgery Arthroscopy Instrument Set
Orthopedic Surgical Medical Acl Surgery Arthroscopy Instrument Set for Knee Reconstruction
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Seismic Roof Pipe Bracing Zinc Plated Steel
Seismic Roof Pipe Bracing System Zinc Plated Steel Base Stiffener/Coupling Set
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