Geasure Cervical Disc for Degenerative Cervical Disease | CE/FDA

Natural Biomechanics – Geasure Cervical Disc for Motion Preservation The Geasure Cervical Disc is engineered with a precisely located instantaneous center of rotation matching the native cervical motion segment, enabling coupled flexion‑extension (12°), lateral bending (10°), and axial rotation (10°) with synchronized movement patterns. The unconstrained core design allows self‑adjusting kinematics that adapt to patient-specific cervical alignment, while the concave‑convex articulation surface reduces edge loading—supported by FEA showing a 32% reduction in adjacent annulus stress compared to fusion devices. A prospective, multicenter study (n=160, 24‑month follow‑up) reported a 97.5% success rate per FDA composite criteria, with an average NDI improvement of 41.8 points (from 58.3 to 16.5). The disc demonstrated a 2.2% adjacent segment degeneration rate—well below the 6.4% reported in fusion cohorts.

Quality Embedded at Every Stage – From Material to Final Release At Changzhou Geasure, quality assurance begins with raw material verification (CoCrMo per ASTM F1537, UHMWPE per ISO 5834‑2 with full chemical and mechanical characterization) and continues through every phase of production. In‑process monitoring includes 100% dimensional inspection (CMM, ±0.01 mm tolerance), articular surface profilometry (Ra ≤0.2 μm), and real‑time environmental monitoring in ISO Class 8 cleanrooms. Final product validation includes static compression (≥12,000 N), dynamic fatigue (10 million cycles at 50 N per ASTM F2346), wear simulation (gravimetric wear <2 mg per million cycles), and sterile packaging integrity testing. All products are CE marked (Class III) and FDA approved, supported by ISO 13485, 14001, 50001, and 45001 management systems.