MOTO Partial Knee System Extension

The MOTO Partial Knee System Extension is a portfolio expansion of Medacta's partial knee prosthesis, comprising new MOTO Sphere femoral components (available in 5 sizes with or without TiNbN coating) and 7mm thick MOTO Medial and Lateral tibial inserts made of E-cross material (available in 8 sizes). These components are designed for cemented partial knee replacement when one knee compartment is affected by degenerative disease, fractures, or deformity.

The MOTO Sphere femoral components are made of Co-Cr-Mo per ISO 5832-4 and differ from the Oxford predicate device in coverage dimensions (slightly increased in larger sizes to improve range of motion) and optional TiNbN coating. The 7mm thick E-cross inserts differ from the predicate (K213071) only in thickness, designed to accommodate a larger patient population while maintaining the same fixation, material, biocompatibility, and sterilization approach.

ISO 21536 (contact pressures and range of motion), ASTM F2083-21 (range of motion), ISO 14243-1 and ISO 14243-2 (knee simulator wear testing), European Pharmacopoeia §2.6.14 / USP <85> (bacterial endotoxin testing), and USP <151> (pyrogenicity testing).

The devices are substantially equivalent because the MOTO Sphere's slightly increased AP and PD coverage dimensions serve only to expand range of motion without raising new safety or effectiveness questions, and the TiNbN coating is identical to that already cleared on predicate MOTO devices (K213071). The 7mm thickness expansion of the E-cross inserts broadens the intended patient population but does not introduce different safety or effectiveness concerns, as demonstrated by comparative wear testing and dimensional analysis showing performance equivalent to existing MOTO products.