Engineered to comply with the stringent clinical protocols of the Saudi Food and Drug Authority (SFDA), our advanced trauma and reconstruction systems ensure maximum mechanical stability, absolute biocompatibility, and accelerated bone union rates.
The Kingdom of Saudi Arabia's healthcare sector is undergoing an unprecedented modernization program as part of Saudi Vision 2030. High investment in hospitals, traumatology centers, and specialized orthopedic clinics in Riyadh, Jeddah, and Dammam is driving a massive rise in demand for premium orthopedic implants and screw fixation systems.
As clinical settings scale up to address rising trauma incidents, sports injuries, and demographic shifts, procuring entities such as NUPCO (National Unified Procurement Company) and major hospital chains are shifting towards manufacturing suppliers that demonstrate uncompromising quality, robust regulatory compliance, and consistent supply chain continuity.
Integrating world-class orthopedic screw systems directly supports Saudi Arabia's national health goals, focusing on reducing recovery periods, lowering risk of revision surgeries, and standardizing implant procurement with CE, ISO, and SFDA compliant surgical systems.
Our implants utilize biocompatible Titanium Alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 standards, providing optimized biomechanical properties, high fatigue limits, and superior compatibility with advanced diagnostic imaging like MRI and CT.
Every component, from cortical and locking screws to spine mesh cages, features absolute traceability back to raw material ingots. Supported by a rigorous Quality Management System under 69 QA/QC inspectors.
High-performance osteosynthesis requires careful consideration of thread design, insertion torque, pull-out strength, and stress-shielding mitigation. Explore our technical roadmap below.
For over two decades, our factory has partnered with leading clinical institutions, engineering high-precision orthopedic implants that meet the benchmark standards of European MDR and global ISO regulations.
Explore our secondary catalog of arthroscopy instrument sets, micro-locking plates, and specialized spinal cages designed for operating rooms in Saudi Arabia and worldwide.
Entering the Saudi healthcare environment requires deep familiarity with the regulatory requirements of the Saudi Food and Drug Authority (SFDA). Class III surgical implants, specifically osteosynthesis plates and cannulated compression screws, are subjected to stringent pre-market clearance steps to obtain Medical Device Marketing Authorization (MDMA).
Our manufacturing site coordinates closely with registered authorized representatives within the Kingdom to streamline technical documentation audits, biocompatibility testing validations, and ISO 13485 certification submissions, facilitating efficient customs clearance through King Khalid International Airport in Riyadh and Jeddah Islamic Port.
We implement advanced protective packaging with humidity indicators and tamper-evident indicators. This maintains barrier properties and sterility from our class 10,000 cleanroom environments directly to surgical suites across Saudi Arabia.
We assist institutional buyers and local distributors in Saudi Arabia by providing comprehensive validation reports, including mechanical stress test logs, corrosion resistance data, and cleanroom bioburden validation protocols, ensuring swift SFDA compliance.
Ensuring completeness in traumatic reconstructive surgery, our pediatric-use, spine-fixation, and reconstruction button models address complex orthopedic procedures.
A window into our advanced 29,523㎡ manufacturing plant, displaying our CNC machining centers, automated polishing areas, inspection chambers, and packaging facilities.
Essential technical and commercial information for medical directors, chief distributors, and hospital procurement departments in the Gulf region.
Equip your clinics and hospitals with clinical-grade trauma and reconstruction hardware. Request technical datasheets, regulatory validation files, or a detailed quotation from our sales team.
Harney-Well