Grai Orthopedic Implants
Grai Orthopedic Implants
Direct from our state-of-the-art facility: ISO-certified medical implants, components, and auxiliary industrial assemblies.
Zengyu High Quality 6V 4200mAh Ni-MH Replacement Geb121 Battery for Lei Ca Total Station
View Product Detail →
Railway Construction Parts Sand Casting Steel Parts Rail Shoulder
View Product Detail →
Titanium Orthopedic Pedicle Screw System
View Product Detail →
Non Absorbable Cannulated Peek Interference Arthroscopy Orthopedic Screws
View Product Detail →
Spine Fixation Anterior Cervical Plate System
View Product Detail →
Locking Plate Multi Axial for Distal Radius Fracture Orthopedic Surgery Implants
View Product Detail →
Orthopedic Surgical Mini Combined Type Fragment External Fixator for Fracture Surgery
View Product Detail →
Ambulance Ceiling IV Hook Movable Medical IV Poles
View Product Detail →The global sports medicine and soft tissue repair landscape is witnessing an unprecedented surge. Posterior Cruciate Ligament (PCL) reconstructions require exceptional bio-mechanical stability to restore knee kinematics. For medical device distributors and surgical centers, partnering with an agile OEM/ODM PCL Fixation Manufacturer guarantees accessibility to cutting-edge designs, lower per-unit cost structure, and compliance with the most stringent regulatory bodies globally.
Successful PCL fixations require implantable systems that resist multi-axial shear stresses inside the joint capsule. Current clinical guidelines favor materials like PEEK (Polyetheretherketone) and Bioabsorbable Polymers (such as PLLA-HA) because they mimic the elastic modulus of bone, minimizing stress shielding. As a specialized developer, our factory utilizes high-purity medical polymers sourced with complete traceability back to the original resin compounders.
Western distributors are rapidly transitioning their procurement frameworks towards China's premium medical manufacturing corridors. The driver is not merely cost, but high-density technological convergence: ultra-precision Swiss CNC machining centers, proprietary surface anodizing treatments, and dedicated Class 10,000 cleanrooms operating under ISO 13485 frameworks. This guarantees immediate access to high-volume production without quality trade-offs.
Explore our 15,000 m² modern facility executing precise machining, cleanroom packaging, and meticulous QA testing.
Our machining line features multi-axis precision milling setups to fabricate implants with dimensional tolerances tighter than ±0.005mm.
Equipped with video measuring machines (VMM), tensile strength testers, and optical comparators to verify thread profiles and biomechanical limits.
Class 100,000 (ISO Class 8) environment ensuring zero particulate contamination prior to double-sterile barrier medical packaging.
All medical-grade metals (ASTM F136 Titanium, PEEK-OPTIMA) undergo chemical analysis verification and heat-number tracking.
Dedicated processing lines specializing in cannulated orthopaedic screws, suture anchor eyes, and locking plate threading systems.
Our engineering division creates custom fixtures and dies, accelerating prototyping speed and custom OEM turnaround times.
Anodizing, acid etching, and physical vapor deposition processes to improve the bio-compatibility and osseointegration of bone screws.
Continuous process capability indexing (Cpk) ensures that every shift operates under strict adherence to ISO 13485 guidelines.
A comprehensive analytical breakdown of materials, designs, and biomechanics required for modern soft-tissue anchoring.
The primary surgical mechanism for PCL graft fixation involves mechanical compression between a cannulated screw and a tunnel drilled into the femur or tibia. Our R&D team addresses two primary challenges: maintaining high insertion torque limits and ensuring maximum pull-out force. By employing 3D modeling (FEA) and dynamic torsion testing, we design bone-anchor threads that prevent damage to autologous or allogeneic tendons during insertion, while maintaining clinical structural integrity until biological integration occurs.
Whether you require standard titanium alloy (Ti6Al4V ELI) for high-impact durability or PEEK-OPTIMA® polymers for artifact-free post-operative MRI imaging, our factory executes production with a high degree of process reproducibility. Every product lot comes documented with material certification sheets, showing a linear correlation with international ASTM specifications.
We provide full sterile-barrier configuration design, implementing Tyvek pouches, blister nesting, and specialized regulatory labelling conforming to Unique Device Identification (UDI) regulations under FDA and EU MDR.
Accelerate your time-to-market. Our engineering team designs 10+ new products monthly, leveraging rapid 3D printing and quick-turn CNC setups to produce clinical evaluation samples inside short timelines.
Reflecting our absolute trust in our quality control, all orthopaedic systems and tooling kits are backed by a comprehensive 1-year product replacement warranty, coupled with expert technical integration support.
Adapting manufacturing practices to meet shifting regulatory landscapes, material science updates, and clinical demands.
In arthroscopic surgery, traditional bioresorbable polymers like PLLA/PLDLA have shown limitations, occasionally leading to localized inflammatory responses or tunnel widening. Sourcing departments are now targeting composite polymers—particularly PEEK enriched with calcium phosphates or bioactive ceramic particles to enhance direct bone apposition.
Our facility remains at the cutting edge of this development. We provide co-molding and precision machining of advanced medical plastics, ensuring the correct density distribution is maintained in the final molded implant. This capability allows our contract buyers to launch premium-grade implant systems that capture high-margin clinical sectors.
Our ISO 13485 processes also document full process validation (IQ/OQ/PQ) for customized injection molding or CNC-milling operations, offering an audit-ready dossier to facilitate regulatory approval pathways in Europe and North America.
Essential insights on regulatory pathways, technical validation, production capabilities, and logistics protocols.
We supply full raw material traceability reports. For titanium implants, we utilize medical-grade titanium alloy conforming to ASTM F136. For polymer implants, we utilize PEEK material conforming to ASTM F2026. Every shipment is accompanied by a material mill certificate and chemical analysis report, ensuring raw material integrity is maintained throughout the production loop.
Our manufacturing systems operate under ISO 13485 quality frameworks. We provide complete technical validation dossiers (IQ/OQ/PQ), sterilization validations, packaging stability data, and mechanical fatigue test results. This technical file support makes the registration and clearance process under FDA 510(k) or EU MDR regulatory structures straightforward for our OEM/ODM partners.
MOQ depends heavily on the production technology and tooling complexity. For standard sizes of titanium or PEEK screws utilizing existing programming, we offer low MOQ starting points (typically 50-100 units). For custom injection-molded components requiring specialized tool development, MOQs generally start at 500 units. We offer prototype runs to support clinical trials and evaluation phases prior to scaling production.
Yes. We specialize in producing comprehensive, sterilized-ready surgical instrument kits (including driver shafts, cannulated drills, depth gauges, and tap handles). This integrated packaging approach ensures precise compatibility between the implant and its respective delivery tools, minimizing intraoperative complications.
We offer both sterile-packaged and non-sterile bulk configurations. For sterile-packaged products, we utilize either Ethylene Oxide (EO) gas sterilization or Gamma irradiation, validated in accordance with ISO 11135 or ISO 11137 standards. Packaging is validated for shelf-life integrity via accelerated aging testing under ASTM F1980.
Explore additional products in our manufacturing lineup, ranging from external fixators and joint systems to chemical filter elements.
Elbow External Fixator Medium Tubular Bones Fracture Fixation Elbow Hinge Fixator
View Product Detail →
Acl Pcl Surgery Instrument Orthopedic Metal Arthroscopy Suture Anchors
View Product Detail →
Instruments for Knee Replacement Surgery Artificial Hip Joint System Hip Joint Replacement Prosthesis
View Product Detail →
Acl Interference Screw for Knee Arthroscopy Peek Screw Interference Screw Instrument Set
View Product Detail →
OEM ODM Custom Wastewater Treatment Chemical Filter System for Plating Line Effluent
View Product Detail →
Advanced Orthopedic Spine Instrument Set for Spinal Surgery
View Product Detail →
Intramedullary Nail System Expert Tibial Interlocking Nail Suprapatellar Approach
View Product Detail →
Advanced Shoulder Abduction Brace for Ultimate Comfort and Stability
View Product Detail →