FDA cleared the Momentum Acetabular Cup System from United Orthopedic Corporation on Sep 2, 2026 under K253948, a traditional 510(k). The device falls under product code LZO, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, regulated at 21 CFR 888.3353 as a Class 2 device. The review panel was Orthopedic.
FDA logged the submission as received on Dec 10, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
United Orthopedic Corporation has one other decision in the tracker over the last 12 months: K252725 (Stem Extension Line (U2 Total Knee System—PSA Type)).