Mfinity Femoral System

The Mfinity Femoral System is a cementless hip prosthesis stem made of titanium alloy coated with titanium plasma spray and hydroxyapatite. It is intended for total or partial hip arthroplasty to replace the native femoral neck in primary or revision surgery, indicated for conditions such as osteoarthritis, avascular necrosis, fractures, and failed previous hip surgeries.

The Mfinity differs from predicate devices in CCD angle, stem length, and neck offset. However, its CCD angles are shared with other Medacta predicates, stem lengths overlap with predicate devices AMIStem-P and Quadra-P, and its slightly larger neck offset is supported by mechanical evaluation. The substrate material and titanium coating are shared with predicate Masterloc.

ISO 7206-4 and ISO 7206-6 (fatigue testing), ISO 21535 (range of motion), European Pharmacopoeia §2.6.14 (bacterial endotoxin test), USP chapter <151> (pyrogen test), ASTM F1580 (titanium plasma spray coating), ASTM F1185 (hydroxyapatite coating), and ISO 5832-11 (titanium alloy material).

Although the Mfinity differs in CCD angle, stem length, neck offset, and materials from the primary predicate (Actis DuoFix K210581), all differences are accommodated by other Medacta predicate devices or supported by mechanical testing data. The devices share identical fixation method, taper design, biocompatibility profile, packaging, and sterilization. No new safety or effectiveness concerns arise because dimensional variations are bracketed by existing cleared devices and material properties are validated through established coating and substrate predicates.