Cleared Traditional

Exactech? Alteon? Short Tapered Wedge

K221323 · Exactech, Inc. · Orthopedic

May 2023

Decision

378d

Days

Class 2

Risk

About This 510(k) Submission

K221323 is an FDA 510(k) clearance for the Exactech? Alteon? Short Tapered Wedge, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on May 19, 2023, 378 days after receiving the submission on May 6, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K221323 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2022
Decision Date	May 19, 2023
Days to Decision	378 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