EPORE® XO cup system

The EPORE® XO cup system is a hip joint replacement device consisting of additively manufactured acetabular cups with a porous outer surface, polyethylene inserts, optional bone screws, and femoral heads. It is intended for total hip arthroplasty in patients with osteoarthritis, rheumatoid arthritis, femoral neck fractures, or failed previous hip replacements, using uncemented biological fixation.

The device features the same basic hip replacement construct as its predicate (metallic acetabular cup, polyethylene insert, ceramic/metallic femoral head with stem/taper components) and is designed for uncemented biological fixation. The primary technological difference is the use of additive manufacturing to create the porous outer surface (EPORE®), which is supported by regulatory precedence from an additively manufactured reference device.

Not stated in this summary.

The EPORE® XO cup system is substantially equivalent to the EcoFit® Hip System predicate because both devices have identical indications for use, the same fundamental hip replacement technology and materials, and comparable performance. Testing demonstrates the subject device meets pre-defined acceptance criteria for hip arthroplasty devices, and minor differences in design are supported by regulatory precedent and pose no significant safety or effectiveness risks.