Resolve Modular Revision Hip Stem— 510(k) K242315

Name: FDA 510(k) clearance K242315
Creator: U.S. Food and Drug Administration
Published: 2025-05-01

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K242315 for Resolve Modular Revision Hip Stem, Substantially Equivalent on 2025-05-01. Applicant: United Orthopedic Corporation. Device class: 2.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2024-08-05
Decision date: 2025-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu City, TW

Download summary PDF View on FDA.gov ↗

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K251052 — Trivicta® Hip Stem2025-05-22
K243839 — Alteon® HA Femoral Stems2025-03-10

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
K243466 — Conformity Stem Extension Line, #02025-01-06

Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.