Velora Acetabular System

The Velora Acetabular System is a total hip replacement device consisting of titanium alloy acetabular cups with an additively manufactured 3D-printed porous surface (TIDAL Technology) paired with polyethylene liners in various geometries. It is intended for cementless fixation in skeletally mature patients undergoing hip replacement for osteoarthritis, trauma, avascular necrosis, fractures, or revision surgery using anterior or posterior surgical approaches.

The Velora Acetabular System differs from its predicate (K190904) by being additively manufactured with an integrally built 3D-printed porous surface, whereas the predicate uses conventional manufacturing. The device maintains the same metal/polymer/metal semi-constrained design and cup sizes (40mm to 72mm) with multiple liner geometries.

ASTM F1820 (axial, lever-out, and torque-out disassembly), ASTM F2582 (liner impingement), ASTM F3090 (acetabular cup fatigue), ISO 21535 (range of motion), ISO 7206-12 (acetabular cup deformation), ASTM F2924 (titanium alloy specification), ASTM F2695 and F2565 (polyethylene specifications).

Substantial equivalence is established because the Velora Acetabular System shares identical indications for use and intended use with predicate K190904, meets the same acceptance criteria for performance testing, and shares similar designs and sizes with reference devices EMPHASYS and G7. The technological differences in additive manufacturing and 3D-printed porous surface were assessed through mechanical testing and do not raise different questions of safety or effectiveness.