Discover our precision-engineered, CE-marked Class III surgical implants designed for spinal, trauma, and extremity reconstructive procedures.
Modern screw fixations utilize variable thread designs and expandable cores to distribute mechanical load uniformly across trabecular bone structure, reducing risk of screw pullout or bone resorption.
Integrating PEEK cages with titanium-alloy pedicle screws provides a radiolucent fusion window, enabling surgeons to easily track postoperative bone growth and fusion progress.
Global regulatory landscapes, specifically the transition from MDD to MDR in Europe and rigorous NMPA approvals in China, demand absolute compliance from medical screw manufacturers.
Utilizes polyaxial and monoaxial pedicle screws (such as the COX system) combined with rods to stabilize segment degeneration, spinal trauma, or scoliosis. The expansive designs ensure strong anchorage even in osteoporotic bone.
Features anterior cervical plates and cervical interbody fusion PEEK cages to restore disc height and fixate structural columns following discectomy procedures.
Employs titanium locking plates (humeral, femoral) alongside spiral blade intramedullary nails to secure subtrochanteric fractures, humeral shaft fractures, and distal tibia fractures.
Demands micro-cannulated screw systems. Precision-guided cannulated screws are inserted over guide wires to fixate scaphoid, calcaneal, and hallux valgus corrective osteotomies.
Reputable factories enforce a strict inspection protocol on all products, using laser micrometer measuring tools to check critical dimensions, including thread pitch, lead, and hex drive depths.
Products must be processed within ISO Class 7 cleanrooms (Class 10,000) and packaged in double-sterile blister packs or Tyvek pouches, ready for Gamma-irradiation or EO gas sterilization.
Advanced supplier networks support customized sample processing, graphic engraving, and tailormade bone screw dimensions to support complex regional clinical cases.
An inside look at our manufacturing infrastructure: high-speed CNC precision lathing, quality assurance laboratories, sterile packaging, and certified production workflows.
Explore our specialized orthopedic surgical hardware systems certified to provide absolute spinal stabilization and osteosynthesis recovery.
Get answers to critical technical and regulatory questions about sourcing, materials, certifications, and capabilities.
We strictly utilize implant-grade Titanium Alloy (Ti-6Al-4V ELI) conforming to ASTM F136 standards. This provides high tensile strength, fatigue resistance, and biocompatibility, ideal for high-stress applications like spinal pedicle screws and orthopedic locking plates.
Beijing Fule products are manufactured under a registered ISO 13485 (Certificate No. 04724Q10000818) quality management system. Our primary spinal, cervical, and trauma lines are CE marked, certifying compliance with EU Class III medical device standards, as well as holding NMPA registrations.
Yes. With a dedicated R&D engineering department of 20 professionals and 102 state-of-the-art CNC machines, we offer extensive customization services, including custom graphic engraving, sample processing, and custom product configuration based on buyer specifications.
Quality control is integrated into all production processes. We conduct 100% inspection on all products. Our traceability system allows us to track raw material chemistry logs, CNC machine operator shifts, thermal processing parameters, and cleanroom packaging records back to the original batch.
Standard lead times vary from 15 to 45 days depending on customization complexity. We have over 30 years of export experience, serving international medical device distributors, hospitals, and surgical networks across Eastern Europe, Southeast Asia, South America, and global domestic markets.
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