Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts

K103223 is the FDA 510(k) clearance record for HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, a class II device, cleared for Encore Medical L.P. on 2010-12-21 under FDA product code OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive). FDA's definition for product code OIY reads: "Indicated for: 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...". FDA records list 85 510(k) clearances for Encore Medical L.P., from 2002-08-23 to 2026-01-15. As of 2026-09-10, FDA records show no recalls naming K103223.