Cleared Special

Conformity Stem Extension Line

K242249 · United Orthopedic Corporation · Orthopedic

Aug 2024

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K242249 is an FDA 510(k) clearance for the Conformity Stem Extension Line, 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 August 30, 2024, 30 days after receiving the submission on July 31, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K242249 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2024
Decision Date	August 30, 2024
Days to Decision	30 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