Cleared Traditional

Coated hip implants

K250450 · Medacta International S.A. · Orthopedic

Sep 2025

Decision

213d

Days

Class 2

Risk

About This 510(k) Submission

K250450 is an FDA 510(k) clearance for the Coated hip implants, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on September 19, 2025, 213 days after receiving the submission on February 18, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K250450 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2025
Decision Date	September 19, 2025
Days to Decision	213 days
Submission Type	Traditional
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