Cleared Traditional

OPTIX H2 Patient Specific Instrument System

K230462 · Vilex, LLC · Orthopedic

Jul 2023

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K230462 is an FDA 510(k) clearance for the OPTIX H2 Patient Specific Instrument System, a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSN), submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on July 17, 2023, 146 days after receiving the submission on February 21, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K230462 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 2023
Decision Date	July 17, 2023
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3110