Medical-grade surgical titanium, shape memory alloys, and specialized surgical raw stocks engineered for high-load, bio-compatible applications.
Hangzhou Retra Medical Co., Ltd. — Pioneering Next-Generation Surgical Fasteners and Bio-Metallurgical Innovation
Hangzhou Retra Medical Co., Ltd. is a premier global manufacturer of high-performance medical metals and orthopedic implants, specializing in state-of-the-art Medical Titanium, Stainless Steel (316LVM), CoCrMo, Tantalum, and Nitinol.
With an unyielding commitment to advanced metallurgical research, development, and ultra-precision manufacturing, Retra Medical has established itself as an indispensable OEM/ODM contract manufacturing partner for top-tier hospitals, surgical centers, and medical device brand owners around the globe.
Guided by our foundational principles of "Quality First, Innovation-Driven, Customer-Oriented," we combine certified quality management systems with cutting-edge Swiss CNC milling, micro-wire EDM, and automated surface passivation to ensure absolute zero-defect delivery.
Our company offers a comprehensive range of orthopedic and surgical implants, engineered to solve the most complex clinical challenges. Our device solutions encompass joint replacement components, spinal fixation systems, trauma plates and screws, maxillofacial reconstruction devices, surgical ligating clips, and bespoke custom implant solutions.
Every fastener, clip, rod, and plate is fabricated exclusively using high-purity surgical-grade metals. These materials guarantee exceptional biocompatibility, structural durability, and extreme corrosion resistance, fully satisfying and exceeding the strict regulatory benchmarks set by FDA, CE MDR, and ISO 13485 oversight bodies.
Delivering domain-specific OEM/ODM surgical clip and fastener platforms tailored for modern minimally invasive and open surgical interventions.
Custom OEM titanium ligating clips and polymeric hemoclip delivery mechanisms engineered for laparoscopic cholecystectomy, bariatric, and gynecological procedures. Designed with chevron-notch profiles to prevent clip slippage and ensure tactile feedback during vessel occlusion.
High-tensile Grade 5 (Ti-6Al-4V ELI) titanium locking screws, cortical bone fasteners, and Nitinol memory compression staples. Tailored to dynamic bone healing environments requiring controlled spring-back force and zero micro-motion wear.
Precision-drawn radiopaque Nitinol clips and Cobalt-Chromium (CoCrMo UNS R31233) micro-fasteners built for vascular repair, sutureless anastomotic sealing, and delicate aneurysm neck clamping where ultimate fatigue strength is mandatory.
Ultra-low-profile titanium plates, mesh fasteners, and cranial fixators designed for delicate soft-tissue-to-bone fixation and facial reconstruction, ensuring minimal skin palpability and complete MRI compatibility.
Comparative technical data for key medical-grade alloys deployed across our OEM/ODM surgical clip and fastener product lines.
| Material Standard | Composition / Grade | Tensile Strength (MPa) | Biocompatibility Standard | Primary Clinical Application |
|---|---|---|---|---|
| ASTM F136 / ISO 5832-3 | Ti-6Al-4V ELI (Grade 23 Titanium) | ≥ 860 | ISO 10993 / ASTM F981 | Hemostatic Ligating Clips, Orthopedic Trauma Screws |
| ASTM F2063 | Nitinol (Nickel-Titanium Shape Memory) | 800 - 1500 (Superelastic) | ISO 10993 / USP Class VI | Self-Closing Vascular Clips, Dynamic Compression Staples |
| ASTM F138 / S31673 | 316LVM (Vacuum Melt Stainless Steel) | ≥ 650 (Annealed) / ≥ 930 (Hard) | ISO 10993 / ASTM F981 | Surgical Staples, Temporary Ligation Clips, Bone Wires |
| ASTM B815 / UNS R31233 | Ultimet 720 Cobalt-Chromium-Nickel-Moly | ≥ 950 | ISO 10993 Compliance | High-Stress Wear Fasteners, Structural Joint Anchors |
| ASTM B351 / UNS R60704 | Pure Zirconium / Zircaloy Grade | ≥ 450 | ISO 10993 Compliance | Artifact-Free Imaging Anchors, Specialized Dental Fasteners |
From metallurgical raw material sourcing to cleanroom packaging: Our validated pipeline guarantees turnkey execution for medical device brands.
Collaborative CAD/CAM engineering assistance. Finite Element Analysis (FEA) optimizes clip retention strength, crimp yield mechanics, and stress distribution prior to tooling creation.
Multi-axis Swiss turning centers and ultra-fine wire electrical discharge machining capable of holding sub-micron tolerances (±0.002mm) on intricate micro-fastener geometries.
Validated citric/nitric acid passivation according to ASTM F86 standards. Color-coded Type II titanium anodizing facilitates clear visual identification during fast-paced surgical operations.
ISO Class 7 and Class 8 cleanroom environments. Automated ultrasonic multi-stage washing, non-destructive optical sorting, and customizable blister tray/Tyvek pouched OEM packaging.
Mitigating global market access risk through exhaustive documentation, rigorous testing, and internationally harmonized quality systems.
Our operational infrastructure operates under a strictly enforced Quality Management System (QMS) specifically tailored for medical device design and manufacturing, ensuring consistency across high-volume production batches.
We provide full Device Master File (DMF) documentation, technical data packages, material certification certificates (MTR), and complete audit support to streamline your regulatory clearance pathways worldwide.
All surgical clips, staples, and metallic alloys undergo stringent evaluation per ISO 10993 standards, including cytotoxicity, systemic toxicity, hemocompatibility, and long-term corrosion resistance testing.
Anticipating the evolution of surgical mechanics through bioresorbable metallurgy, additive micro-manufacturing, and AI quality monitoring.
Pioneering OEM research into bioresorbable Magnesium (Mg) and Zinc (Zn) alloy clips designed to provide temporary tissue ligation and gradually resorb, eliminating permanent foreign body presence.
Integrating Selective Laser Melting (SLM) to manufacture ultra-lightweight titanium implants with bio-mimetic porous structures that promote direct osseointegration at the bone-fastener interface.
Deploying deep-learning computer vision inspection systems directly inline with machining centers to verify critical clip dimensions and surface integrity with 100% real-time accuracy.
Technical and commercial insights for medical device procurement leaders, R&D directors, and OEM project managers.
We specialize in medical-grade Titanium (Grade 5 Ti-6Al-4V ELI per ASTM F136 and Grade 2 per ASTM F67), Nitinol shape memory alloys (ASTM F2063), vacuum-melted 316LVM Stainless Steel (ASTM F138/F139), Cobalt-Chromium alloys (ASTM B815 / UNS R31233), Pure Zirconium (UNS R60704), and Tantalum for specialized radiopaque markers.
MOQs vary based on component complexity and raw material requirements. For custom CNC-machined titanium fasteners or prototype surgical clips, MOQs start as low as 500–1,000 units. Prototype tooling lead times generally range from 3 to 4 weeks, with full-scale production runs delivered within 6 to 8 weeks after DFM approval.
Yes. As an ISO 13485:2016 certified contract manufacturer, we provide complete technical documentation dossiers including Certificates of Analysis (CoA), Raw Material Traceability (MTR), Passivation Reports (ASTM F86), Biocompatibility Summary Test Reports (ISO 10993), and Sterilization Compatibility Data (EtO / Gamma / Autoclave).
Our engineering team designs clips with precise chevron or micro-grooved inner surfaces that provide mechanical mechanical interlocks against soft tissue. Additionally, strict metallurgical tempering and precise cold-working procedures are applied to titanium and Nitinol to guarantee optimum yield strength and minimal rebound force.
Yes, we offer electrochemical passivation, electropolishing, and Type II anodization in standard surgical colors (green, blue, gold, magenta). Anodizing enhances corrosion resistance, eliminates glare under operating room lighting, and enables color-coded identification for varying staple sizes or screw lengths.
We operate ISO Class 7 validated cleanrooms for final washing, inspection, and primary packaging. Options include thermoformed blister trays, medical-grade Tyvek pouches, pre-sterilized bulk packs, and customized private-label boxing ready for hospital distribution.
Additional specialized surgical bars, wire solutions, cranio plates, and precision medical implant stock.
Retra Medical
