Cleared Special

Z1 Hip System

K251906 · Zimmer, Inc. · Orthopedic

Jul 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K251906 is an FDA 510(k) clearance for the Z1 Hip System, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 18, 2025, 28 days after receiving the submission on June 20, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K251906 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2025
Decision Date	July 18, 2025
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353