Momentum Acetabular Cup System— 510(k) K253948

Name: FDA 510(k) clearance K253948
Creator: U.S. Food and Drug Administration
Published: 2026-09-02

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K253948 for Momentum Acetabular Cup System, Substantially Equivalent on 2026-09-02. Applicant: United Orthopedic Corporation. Device class: 2.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2025-12-10
Decision date: 2026-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaohsiung City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZO

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K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various)2026-07-06
K260831 — Z1 Hip System2026-06-16
K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
K260037 — implantcast Packaging System Update2026-03-30
K252401 — implaFit® short stems2026-03-12

More clearances from United Orthopedic Corporation

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K252725 — Stem Extension Line (U2 Total Knee SystemPSA Type)2025-09-25
K252303 — Stem Extension Line (USTAR II System)2025-08-22
K243656 — U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella2025-07-31
K242315 — Resolve Modular Revision Hip Stem2025-05-01
K243466 — Conformity Stem Extension Line, #02025-01-06

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.