Rigorous Quality Control
Multi‑Stage Quality Control – Micro‑CT, Mechanical Testing, and Dimensional Verification
Every porous surface spinal implant undergoes a comprehensive 15‑step quality control protocol, including micro‑CT scanning (10 µm resolution) to verify pore size (300–600 µm), porosity (65–75%), and interconnectivity across 100% of production batches. Mechanical testing per ASTM F1717/F2077 includes static compression (≥8,000 N), dynamic fatigue (5 million cycles at 500 N), and torque testing (≥8 N·m). Dimensional inspection uses CMM (±0.05 mm tolerance) and optical profilometry for surface roughness (Ra ≤0.4 µm for non‑porous regions).
Since 2021, 100% of porous implant lots have passed final release on first inspection, with a post‑market complaint rate of 0.07% across 8,200 porous surface implants. Each implant is serialized, with complete quality documentation including micro‑CT reports, mechanical test data, and dimensional records.