Explore our high-precision surgical systems designed for trauma, spine, joint reconstruction, and sports medicine.
In modern spinal reconstructive surgery, the polyaxial pedicle screw stands as a cornerstone of internal fixation. Designed to address complex spinal pathologies—ranging from degenerative disc disease and spondylolisthesis to severe scoliosis and traumatic fractures—the polyaxial design offers surgeons an unparalleled degree of angulation. This mechanical freedom simplifies rod alignment, reduces stress concentration at the bone-screw interface, and minimizes the risk of construct failure.
Globally, the spinal implant market is experiencing a significant paradigm shift. Driven by an aging population, rising clinical preferences for Minimally Invasive Spine Surgery (MISS), and the rapid expansion of healthcare infrastructure in emerging economies, the demand for high-quality, cost-effective spinal hardware has reached an all-time high. For medical device brands, distributors, and hospital networks, securing a reliable OEM/ODM polyaxial pedicle screw manufacturer with robust regulatory clearance is critical to capturing market share and ensuring patient safety.
How HBM Medical translates complex biomechanical requirements into high-precision clinical realities.
Operating across a 30,343 m² facility, HBM utilizes 12 specialized production lines equipped with over 120 high-precision CNC Swiss-type lathes, multi-axis machining centers, and automated surface treatment systems to guarantee sub-micron tolerances.
Our R&D division consists of 31 dedicated engineers, including 1 PhD and 11 postgraduates. We offer comprehensive OEM/ODM customization, transforming raw concepts, 2D/3D drawings, or clinical samples into optimized, market-ready implants.
With 36 full-time QA/QC inspectors, we enforce rigorous testing at every stage. From 100% raw material spectroscopic verification to dynamic fatigue testing (ASTM F1717) and coordinate measuring machine (CMM) dimensional checks.
Standard and customizable parameters for our spinal implant systems.
| Parameter | Standard Specification | Customization Options (OEM/ODM) |
|---|---|---|
| Material | Medical Grade Titanium Alloy (Ti-6Al-4V ELI) | ASTM F136 | Cobalt-Chromium (CoCr), PEEK, Surface-treated Titanium |
| Screw Diameter | Ø 4.0mm, Ø 4.5mm, Ø 5.5mm, Ø 6.5mm, Ø 7.5mm | Micro-pedicle (Ø 3.0mm - 3.5mm) for Pediatric/Veterinary |
| Screw Length | 25mm to 60mm (in 5mm increments) | Extended lengths up to 100mm for complex reconstructions |
| Angulation Range | ± 25° (50° total conical range) | Uniplanar, Monoaxial, or Hyper-polyaxial (up to ± 30°) |
| Thread Profile | Dual-lead, self-tapping, variable pitch | Single-lead, cannulated for MIS, fenestrated for cement injection |
| Surface Treatment | Anodized (Type II / Type III), Acid-etched | Hydroxyapatite (HA) coating, porous plasma spray |
Navigating the regulatory landscape of medical devices requires absolute transparency and rigorous adherence to international frameworks. HBM Medical is certified under ISO 13485, MDSAP (Medical Device Single Audit Program), and holds multiple CE MDR certifications (EPT 0477.MDR.25/5905 & EPT 0477.MDR.25/5973).
Our MDSAP certification streamlines market entry across the United States, Canada, Australia, Brazil, and Japan by unifying auditing requirements. We provide complete technical documentation, Device Master Records (DMR), and validation protocols (IQ/OQ/PQ) to support our OEM/ODM partners through local registration processes.
Every single batch of titanium alloy processed in our facility undergoes strict spectroscopic analysis to verify chemical composition and mechanical properties. We maintain 100% raw material traceability, linking every finished pedicle screw back to its original ingot melt.
Our cleanrooms operate under strict ISO Class 7 (Class 10,000) standards, ensuring that bioburden and particulate levels are kept far below regulatory thresholds. This meticulous control minimizes the risk of post-operative infections and promotes rapid, stable osseointegration.
Certificate: C730178
Class III Spinal Implants
How HBM Medical is pioneering next-generation smart implants and additive manufacturing.
Integrating 3D-printed porous structures directly onto the screw shank and fusion cages to mimic natural bone architecture, accelerating osteogenesis and biological fixation.
Developing nano-structured silver-doped hydroxyapatite (HA) coatings that actively suppress bacterial colonization while simultaneously promoting bone-to-implant bonding.
Optimizing screw head geometries and instrumentation for seamless integration with surgical robotic systems and real-time intraoperative optical navigation platforms.
A visual tour of our advanced production lines, testing laboratories, and cleanrooms.
Total Production & Research Footprint
Expert answers to critical questions regarding OEM/ODM collaboration, materials, and regulatory standards.
Discover our comprehensive range of surgical instruments, power tools, and specialized spinal implants.
HBM Medical
