Cleared Traditional

Conformity Stem Extension Line, #0

K243466 · United Orthopedic Corporation · Orthopedic

Jan 2025

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K243466 is an FDA 510(k) clearance for the Conformity Stem Extension Line, #0, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by United Orthopedic Corporation (Hsinchu City, TW). The FDA issued a Cleared decision on January 6, 2025, 59 days after receiving the submission on November 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K243466 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 2024
Decision Date	January 06, 2025
Days to Decision	59 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