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The Tracker / September 2026 / K253948

510(k) cleared

Momentum Acetabular Cup System

United Orthopedic Corporation · Sep 2, 2026 · K253948

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.

This is the only decision on file for United Orthopedic Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253948?

K253948 is the FDA 510(k) for Momentum Acetabular Cup System, submitted by United Orthopedic Corporation. FDA's decision date was Sep 2, 2026, under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented).

Who makes the Momentum Acetabular Cup System?

United Orthopedic Corporation, based in Kaohsiung City, is the applicant of record for K253948.

How long did the K253948 review take?

FDA received the submission on Dec 10, 2025 and issued its decision on Sep 2, 2026, 266 days later.

← All decisions in September 2026