Cleared Traditional

K230717 - Exactech® Vantage® Total Ankle System

K230717 is an FDA 510(k) clearance for Exactech Vantage Total Ankle System, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code HSN cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K230717 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
211d
Days
Class 2
Risk

K230717 is an FDA 510(k) clearance for the Exactech® Vantage® Total Ankle System. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 12, 2023 after a review of 211 days - an extended review cycle.

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 Exactech, Inc. devices

FDA 510(k) Submission Details - K230717

510(k) Number K230717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2023
Decision Date October 12, 2023
Days to Decision 211 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
89d slower than avg
Panel avg: 122d · This submission: 211d
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 65
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K230717.
restor3d Kinos Axiom Total Ankle System
K240591 · Restor3D, Inc. · Apr 2024
QUANTUM® Patient Specific Instrumentation (PSI) System
K231699 · In2bones Sas · Apr 2024
Kinos Axiom Total Ankle System
K232595 · Restor3d · Nov 2023
Vantage® Total Ankle System
K232002 · Exactech, Inc. · Sep 2023
OPTIX H2 Patient Specific Instrument System
K230462 · Vilex, LLC · Jul 2023
QUANTUM Patient Specific Instrumentation (PSI) System
K230313 · In2bones Sas · Apr 2023