Cleared Traditional

Resolve Modular Revision Hip Stem

K242315 · United Orthopedic Corporation · Orthopedic

May 2025

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K242315 is an FDA 510(k) clearance for the Resolve Modular Revision Hip Stem, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by United Orthopedic Corporation (Hsinchu City, TW). The FDA issued a Cleared decision on May 1, 2025, 269 days after receiving the submission on August 5, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K242315 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2024
Decision Date	May 01, 2025
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353