Cleared Traditional

ONVOY? Acetabular System

K243456 · Globus Medical, Inc. · Orthopedic

Jun 2025

Decision

211d

Days

Class 2

Risk

About This 510(k) Submission

K243456 is an FDA 510(k) clearance for the ONVOY? Acetabular System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on June 6, 2025, 211 days after receiving the submission on November 7, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K243456 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 2024
Decision Date	June 06, 2025
Days to Decision	211 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358