Orthopedic Screw Supplier & Company in Spain

Under Regulation (EU) 2017/745, orthopedic bone screws generally fall under Rule 8 for implantable medical devices. Standard cortical and cancellous trauma screws intended for internal fixation are classified as Class IIb. Headless cannulated compression screws and locking screws also fall under Class IIb. Spinal pedicle screws and implants with bioactive coatings or delivery mechanisms may be governed by Class IIb or Class III requirements. ZATH maintains ISO 13485:2016 audited quality systems, and our Technical Documentation Dossiers are fully mapped to Annex II and III to facilitate frictionless registration under AEMPS in Spain.

Yes. For all OEM and ODM partnerships serving the Iberian Peninsula, we provide full localization support. This includes direct fiber-laser marking on the screw head or shaft (displaying diameter, length, batch lot number, and custom brand trademark), multilingual packaging incorporating Spanish, and Instrucciones de Uso (IFU) translated in accordance with Spanish AEMPS mandates and MDR Article 10 guidelines.

We machine our titanium screws from certified Medical Grade 5 Ti-6Al-4V ELI (Extra Low Interstitial) conforming strictly to ASTM F136 and ISO 5832-3. We also machine high-nitrogen cold-worked implant-grade Stainless Steel 316LVM conforming to ASTM F138 / ISO 5832-1. Every batch shipment is supplied with complete raw material mill test certificates confirming chemical composition (oxygen, nitrogen, hydrogen, and carbon ceilings) and tensile/yield elongation parameters.

Quality control testing is conducted in-house on calibrated biomechanical test frames in accordance with ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws). We test torsional yield strength, maximum torque to fracture, angle of rotation at break, insertion torque, and axial pull-out load using certified rigid polyurethane foam blocks (ASTM F1839). Detailed testing reports are provided for hospital tender dossiers.

We offer both configurations. For hospitals and distributors in Spain adopting single-use sterile traceability, we offer Class 7 (10,000) cleanroom packaged products in dual-barrier medical Tyvek® blisters pre-sterilized via Ethylene Oxide (EO) or Gamma irradiation, complete with ISO 11607 validation and a 5-year shelf life. Alternatively, we supply bulk cleanroom-washed screws for consignment hospital graphic caddy sets suitable for local steam autoclaving.

Standard stock orders are dispatched within 48 to 72 hours via DHL Express, FedEx Priority, or air freight directly into Madrid-Barajas (MAD) or Barcelona-El Prat (BCN) airports, typically clearing customs in 4 to 6 business days. For customized OEM production runs, tooling and manufacturing turnaround generally ranges between 3 to 5 weeks depending on volume and surface treatment requirements. All shipments are accompanied by complete commercial invoices, packing lists, EUR/DUA documentation assistance, and Certificate of Origin documents.

For standard catalog specifications with our brand or neutral packaging, MOQ can be as low as 50 to 100 units per size to support market registration or tender pilot evaluations. For bespoke custom designs involving custom thread whirl geometries, non-standard driver slots, or proprietary plate countersinks, our typical production run starts at 300 to 500 units per specification.

By leveraging integrated in-house manufacturing, multi-axis automated CNC technology, and centralized raw material procurement in Beijing, ZATH provides high-tier osteosynthesis screws at a 35% to 50% cost advantage compared to Western European multinational suppliers. This substantial margin relief enables Spanish distributors to bid competitively in public autonomous hospital tenders while preserving healthy distribution profits.