Cleared Traditional

G7? Revision Acetabular System

K252623 · Zimmer, Inc. · Orthopedic

Feb 2026

Decision

169d

Days

Class 2

Risk

About This 510(k) Submission

K252623 is an FDA 510(k) clearance for the G7? Revision Acetabular System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 4, 2026, 169 days after receiving the submission on August 19, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K252623 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2025
Decision Date	February 04, 2026
Days to Decision	169 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