Device Dossier

Vanguard XP Femoral Porous coat with pegs - Coated knee femur prosthesis

Device Dossier for Vanguard XP Femoral Porous coat with pegs - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III, sponsor Zimmer…

Intended purpose

The Vanguard XP femoral porous component with pegs is intended for use as part of the Vanguard XP Knee System, for use with Vanguard CR, CRL, AS, XP-XP, XP-AS bearings. Indications for use include: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; correction of varus, valgus or post-traumatic deformity; correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The titanium alloy porous plasma spray coated chrome cobalt molybdenum alloy component is intended for use without bone cement.

Functional description

Cast CoCrMo alloy femoral component with Ti alloy PPS coating. Semi-constrained type of knee replacement allows for PCL and ACL to remain intact. Asymmetric femoral component supports physiologic motion. Two modular distal pegs may be removed to allow for attachment of femoral augments in the case of bone deficiencies.

TGA Public Summary