Precision-engineered solutions spanning joint reconstruction, trauma fixation, and sports medicine. Certified under global regulatory standards.
In the rapidly evolving landscape of sports medicine and joint reconstruction, the demand for high-strength, low-displacement cortical fixation devices is at an all-time high.
As a specialized custom OEM Endobuttons manufacturer and factory, we deliver clinically proven solutions for anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstructions. Cortical suspensory fixation represents the gold standard in soft tissue graft attachment, providing unparalleled primary mechanical stability. By utilizing biocompatible medical-grade materials such as Grade 5 Titanium (Ti-6Al-4V ELI) and ultra-high-molecular-weight polyethylene (UHMWPE) loop systems, we ensure minimal graft migration and maximum pull-out resistance.
Global OEM buyers, including hospital networks, medical device brand owners, and multinational procurement organizations, face complex challenges regarding supply chain agility, cost efficiency, and regulatory compliance. Our factory addresses these pain points by offering flexible customization options—ranging from loop lengths (15mm to 60mm) and adjustable-loop designs to private labeling and custom sterile packaging solutions. This guarantees seamless integration into surgical kits while elevating clinical performance.
Delivering high-performance manufacturing standards validated by decades of clinical usage and scientific research partnerships.
We have one of the most comprehensive orthopaedics portfolios in the world, we help heal and restore movement for millions of patients. Our products span various specialties, including joint reconstruction, trauma, craniomaxillofacial, spinal surgery, and sports medicine. Building on our proud legacy of industry firsts, we are honoring our commitments to quality and innovation while creating a future where it's easier than ever before to keep people moving.
Pioneering next-generation fixation systems utilizing predictive mechanical modeling, advanced biomaterials, and automated machining processes.
Every single titanium cortical plate features micro-polished chamfered edges. This meticulously engineered round radius profile eliminates high-stress contact zones, effectively preventing suture loop abrasion and graft failure under high dynamic cycling loads.
In addition to Grade 5 Titanium, we produce high-performance PEEK radiolucent Endobuttons. PEEK-OPTIMA® mimics the elastic modulus of native cortical bone, reducing stress shielding and providing clear post-operative radiographic assessments via MRI and CT imaging.
Our loop formulation features ultra-strong UHMWPE core filaments wrapped in textured polyester. Pre-stretched under industrial loading rigs, these loops guarantee sub-millimeter displacement during the critical early graft-healing phase post-surgery.
A step-by-step showcase of our ISO 13485 certified production cycle, maintaining complete traceability and absolute material purity.
Sourcing certified ASTM F136 medical-grade Titanium alloy rods with full material chemical traceability certificates.
Slicing raw alloy rods into optimal operational lengths matching the specified diameter criteria for CNC processing.
Utilizing Swiss-type automatic lathes to establish uniform outer profiles and foundational geometry dimensions.
High-precision drilling of the suture eyelets and fine-tuning geometries utilizing 5-axis CNC machining centers.
Smoothing margins to eliminate burrs and sharp edges that might damage delicate biological soft tissue.
Removing residual machining oils, metal particles, and contaminants through multi-stage industrial ultrasound tanks.
Mechanical grinding for exact dimensional tolerance control, followed by biocompatible surface color anodizing.
Class 10,000 cleanroom packaging in double barrier Tyvek pouches to guarantee long-term implant sterility.
Temperature and humidity monitored warehousing prioritizing FIFO processes, protecting product integrity.
Aligning with clinical research institutions and adhering to global ethics and manufacturing quality criteria.
For more than 60 years, DePuy Synthes has partnered with the AO Foundation aiming to improve patient outcomes and build on our commitment to product and surgical innovation.
This historical alignment underscores our manufacturing philosophy. We prioritize continuous education, clinical evaluation of mechanical failure modes, and iterative engineering. Through collaborative input, we adjust our OEM product specifications to achieve the highest possible standard for surgeons worldwide.
Learn More About the PartnershipAt DePuy Synthes, supporting our partners in care is a key part of our mission. Whether that’s helping fund educational programs for the next generation of healthcare providers, providing medical kits for global healthcare missions, or supporting our industry partners to offer events for industry professionals, we’re dedicated to contributing to the advancement of healthcare across all verticals.
By offering comprehensive hardware resources, dynamic instructional modules, and regulatory-approved prototype samples, we help advance orthopedic science globally.
Learn More About Grants & GivingOur Credo challenges us to put the needs and well-being of the people we serve first. That means we are responsible to the communities in which we live and work and the global community as a whole. We must be good citizens, encourage civic improvements, better health and education, and maintain the property we are privileged to use by protecting the environment and its natural resources.
Explore Our CredoA closer look inside our automated production centers and surgical-grade metal finishing zones.
Ensuring microscopic consistency across thousands of manufactured implant batches.
Precision routing of fixation loops with strict micro-tolerances (+/- 0.005mm).
Automated chemical polishing to achieve mirror finishes without microfracturing titanium plates.
100% optical measurement checks verifying loop retention profiles and anchor shapes.
Strict ISO Class 7/8 packaging environments preventing microbial bioburden contamination.
Enabling direct market access for medical distributors through technical documentation support and localized audits.
We provide global B2B clients with complete technical dossiers, including biomechanical fatigue test logs, ASTM F136 material certificates, biocompatibility studies (ISO 10993), and sterilization validation files to accelerate regional FDA 510(k) and CE MDR registration pathways.
Our entire facility operates under an audited medical device quality management system. From raw bar stock receipt to ultrasonic washing, sterile packaging, and EO sterilization cycles, every process is completely tracked via unique batch records.
We accommodate customized labeling, regional translations, local warehouse safety stock levels, and localized support contacts to resolve import regulatory challenges in North America, Western Europe, Latin America, and Southeast Asia.
Answering key questions on material specifications, sterilization methods, loop strengths, and custom product development capabilities.
We use medical-grade Ti-6Al-4V ELI (Extra Low Interstitials) Grade 5 Titanium Alloy in strict compliance with ASTM F136. This material provides exceptional biomechanical fatigue strength, high corrosion resistance, and superb biocompatibility under long-term load-bearing conditions.
Yes, our factory manufactures continuous loop suspensory devices in standard lengths including 15mm, 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm, and 60mm. We also engineer custom lengths based on specific anatomical studies and client requests.
Our continuous suture loops, manufactured from ultra-high-molecular-weight polyethylene (UHMWPE) and polyester, are certified to withstand loads exceeding 1000 Newtons. This ensures maximum stability and resistance to cyclic elongation during immediate post-operative rehabilitation.
Absolutely. We offer fully validated sterilization services matching ISO 11135 guidelines. Our sterile-packaged Endobuttons are delivered in double-barrier Tyvek pouches, achieving a Sterility Assurance Level (SAL) of 10^-6, ready for direct operating room use.
For private labeling, custom laser marking, and dedicated packaging configurations, our standard MOQ typically ranges from 500 to 1,000 units depending on geometry complexity. We support prototype development for validation trials before ramping up to mass production.
Our cortical button plates feature micro-rounded edges, chamfered eyelets, and electro-polished surfaces. These elements undergo chemical and mechanical testing to verify that there are no sharp edges capable of severing or fraying the graft loop.
Additional orthopedic, spinal, external fixation, and arthroscopic surgical solutions from our advanced catalog.
Nipa Orthopedic Implants
