MobileLink Acetabular Cup System - inhouse coatings

The MobileLink Acetabular Cup System is a hip replacement implant consisting of press-fit titanium alloy shells with two coating options (titanium plasma spray or titanium plasma spray plus calcium phosphate). It is indicated for hip joint diseases including osteoarthritis, rheumatoid arthritis, avascular necrosis, and femoral neck fractures that cannot be treated conservatively. The shells are used for cementless fixation and are compatible with various liners and augments.

The subject device differs from the predicate device only in the coating vendor and manufacturing process. The shells maintain identical design, materials (Ti6Al4V alloy), geometry (cluster hole and multi-hole designs), and coating compositions (TPS and TiCaP). The change introduces an in-house coating process in addition to the existing external supplier.

Not stated in this summary. The document references non-clinical performance testing including characterization of TPS and TiCaP coatings and biocompatibility evaluation, but does not cite specific ISO, IEC, or ASTM standards.

The device is substantially equivalent because the subject shells with in-house PlasmaLink or TiCaP coatings are chemically and physically identical to previously cleared shells differing only in manufacturing source. Non-clinical testing demonstrates that the in-house coatings achieve equivalent performance to the external supplier's coatings in terms of characterization and biocompatibility. Since the coating composition, device design, intended use, and clinical indications are unchanged, and the coating change is a manufacturing vendor substitution with validated equivalent performance, the device functions identically to the predicate.