Regenerex Biomet primary tibial tray - Coated knee tibia prosthesis

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

Zimmer Biomet Pty Ltd

class:

Class III

manufactured_by:

Biomet Orthopedics 56 East Bell Drive, Warsaw, IN, 46581 United States Of America

therapeutic_area:

34198 - Coated knee tibia prosthesis

therapeutic_indication:

Porous titanium tibial tray compatible with four primary articulations within the Vanguard Complete Knee System: CR, CR Lipped, AS, PS. Locking mechanism compresses PE bearing against the tray, utilizing an oversized Ti locking bar that forces the bearing against a 10 degree posterior boss. Tray includes four square, nonporous peripheral pegs to provide initial cancellous bone fixation. Biologic fixation into porous titanium Regenerex construct provides rigid fixation. Packaged with locking bar Porous titanium alloy tibial tray component for use in knee joint replacement due to 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved 2) correction of varus, valgus, or posttraumatic deformity 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure The Regenerex components are intended only for uncemented biologic fixation application.

authorization_status:

Included