Device Dossier

Biomet 360 tibial tray - Prosthesis, internal, joint, knee, total

Device Dossier for Biomet 360 tibial tray - Prosthesis, internal, joint, knee, total (Uncoated knee tibia prosthesis, metallic, Class III, sponsor Zimmer…

Intended purpose

Cobalt chrome alloy tibial tray component of Vanguard 360 revision knee system. Indications for use: 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 or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.

Functional description

Chrome cobalt alloy tibial tray with 25 MM tapered stem boss which accepts offset stem adapters, stem extensions and cruciate wing augments. Nine symmetrical baseplate sizes in 4 MM M/L increments. Packaged with Ti alloy locking bar and screw; intended for cemented use.

TGA Public Summary