Cleared Traditional

OPTIX H2 Patient Specific Instrument System (K230462) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230462 · Vilex, LLC · Orthopedic device
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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

Submission Details

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.

Device Classification

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 55
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K230462.
Kinos Axiom Total Ankle System
K232595 · Restor3d · Nov 2023
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
K230313 · In2bones Sas · Apr 2023
Prophecy Preoperative Navigation Alignment System
K222835 · Wrightmedicaltechnologyinc · Jan 2023
MAVEN™ Patient-Specific Instrumentation
K223227 · Paragon 28, Inc. · Nov 2022