Cleared Traditional

K230462 - OPTIX H2 Patient Specific Instrument System

K230462 is an FDA 510(k) clearance for OPTIX H2 Patient Specific Instrument System, manufactured by Vilex, LLC. The device is a Class 2 Orthopedic device with product code HSN cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K230462 · Vilex, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
146d
Days
Class 2
Risk

K230462 is an FDA 510(k) clearance for the OPTIX H2 Patient Specific Instrument System. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on July 17, 2023 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3110 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Vilex, LLC devices

FDA 510(k) Submission Details - K230462

510(k) Number K230462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 122d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSN Device Classification - Class 2, Special Controls

Product Code HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

All 58
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K230462.
Kinos Axiom Total Ankle System
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Exactech® Vantage® Total Ankle System
K230717 · Exactech, Inc. · Oct 2023
Vantage® Total Ankle System
K232002 · Exactech, Inc. · Sep 2023
QUANTUM Patient Specific Instrumentation (PSI) System
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Prophecy Preoperative Navigation Alignment System
K222835 · Wrightmedicaltechnologyinc · Jan 2023
MAVEN™ Patient-Specific Instrumentation
K223227 · Paragon 28, Inc. · Nov 2022