Engineered with medical-grade titanium and high-performance alloys to deliver robust structural stabilization and accelerate bone healing.
Empowering trauma surgical teams and implant distributors with high-fidelity, bio-compatible trauma hardware engineered for immediate stabilization.
Modern internal and external fixation systems require precise anatomical pre-contouring. Our low-profile locking plates minimize soft tissue irritation while preserving local vascular supply to the periosteum. Specialized titanium locking and compression screw configurations allow surgeons to apply rigid dynamic compression where needed.
By producing advanced intramedullary nails (like the PFNA system) and thoracolumbar polyaxial pedicle screws, we provide global surgical centers with a unified platform. Our surgical instrument sets are designed to withstand thousands of sterilization cycles in high-throughput operating rooms.
For arthroscopic reconstructions, we design fixed and adjustable loop titanium endobuttons that provide high pull-out strength for ACL/PCL tendon fixation. These systems are matched with precision instruments like basket forceps and arthroscopic shaver blades, reducing patient recovery times.
Full institutional transparency backed by third-party auditors and internationally recognized healthcare certifications.
ISO 13485
93/42/EEC
93/42/EEC
EU MDR Compliance
Bridging the gap between strict local regulatory mandates and advanced factory supply lines.
Navigating medical device import regulations can be a bottleneck for hospital procurement teams and brand owners. We assist our global partners in South America (30%), Western Europe (20%), and Southeast Asia (20%) by supplying detailed regulatory dossiers, raw material mill certificates, and biomechanical test protocols.
Whether you require documentation compliance for ANVISA in Brazil, EU MDR in Western Europe, or local health registrations in Southeast Asia, our in-house regulatory affairs team is equipped to expedite the process. Each delivery is backed by an unbroken chain of custody, ensuring that chemical compositions (ASTM F136 / ISO 5832-3) match international biomedical standards.
Our R&D team provides comprehensive custom services, allowing distributors to tailor implants to the specific anatomy and surgical methods of their home markets.
Bridging metallurgy, biomechanics, and active diagnostics to support better patient outcomes globally.
To optimize implant osseointegration and reduce infection risk, we are developing advanced electrochemical coatings. Type II anodization of titanium constructs increases surface porosity, which significantly enhances initial mechanical stability and cellular adhesion while providing high wear resistance.
For pediatric and non-weight-bearing locations, we are testing high-performance magnesium alloy systems and PLA/PHA composites. These implants dissolve gradually over time, matching the rate of new bone formation and eliminating the need for a secondary implant removal surgery.
Our current development focus is on minimizing the anatomical footprint of surgical incisions. By designing smaller percutaneous guides and tissue retractors, we provide surgeons with the tools to insert complex plates and intramedullary nails with minimal trauma to local tissue.
Detailed answers regarding manufacturing standards, metallurgy specifications, and global logistics for distributors.
An inside look at our 29,523㎡ advanced medical device production and testing facility.
Fully biocompatible clinical hardware supporting targeted reconstruction of complex fractures and ligamentous injuries.
Harney-Well
