Versacem Acetabular Shell and Double Mobility HC Liners

The Versacem Acetabular Shell and Double Mobility HC Liners are sterile implantable devices used in total hip arthroplasty for primary or revision surgery. They are indicated for severely painful or disabled joints, avascular necrosis, traumatic fractures, and failed previous hip surgery, with particular use when dislocation prevention is critical and bone quality is poor. The device is intended for cemented use only.

The Versacem Acetabular Shell is a cemented semi-constrained metal/ceramic/polymer prosthesis available in sizes ∅40 to ∅56, compatible with Double Mobility HC Liners (including two new sizes ∅22.2/DMAZ and ∅28/DMC). Key characteristics include general design, articular surface, cementation method, material composition, biocompatibility profile, and packaging. Differences from the predicate include slight variations in size range, shelf-life, and sterilization method.

ISO 11737-3 and European Pharmacopoeia §2.6.14 (bacterial endotoxin testing); USP <151> (in-vivo pyrogenicity in rabbit); USP chapters <85> and <161> (endotoxin quantification). Design validation, wear testing, range of motion evaluation, fatigue testing, pull-off and lever-out tests, jumping distance evaluation, and impingement risk assessment were conducted.

The Versacem Acetabular Shell is substantially equivalent to the NOVAE Stick Dual Mobility Acetabular Cup predicate because both are cemented semi-constrained dual mobility hip prostheses with identical articular surfaces, materials, biocompatibility profiles, and intended use. Differences in size range, shelf-life, and sterilization method do not introduce new safety risks because bench testing validated performance across all sizes, the shelf-life is consistent with other cleared Medacta products, and the sterilization method is fully validated. The Double Mobility HC Liners are substantially equivalent to prior cleared versions because they maintain identical design, material, biocompatibility, and sterilization, with only outer diameter variation that does not affect performance as the inner diameter and articulation remain unchanged.