Cleared Traditional

K151459 - Integra Total Ankle Replacement System (FDA 510(k) Clearance)

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

K151459 · Ascension Orthopedics · Orthopedic device
Aug 2015
Decision
91d
Days
Class 2
Risk

K151459 is an FDA 510(k) clearance for the Integra Total Ankle Replacement System. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Ascension Orthopedics (Austin, US). The FDA issued a Cleared decision on August 31, 2015 after a review of 91 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.

Submission Details

510(k) Number K151459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2015
Decision Date August 31, 2015
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 116d · This submission: 91d
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 11
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K151459.
Kinos Total Ankle System
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APEX 3D Total Ankle Replacement System
K250641 · Paragon 28, Inc. · May 2025
APEX 3D Total Ankle Replacement System
K240259 · Paragon 28, Inc. · Jun 2024
Exactech® Vantage® Total Ankle System
K230717 · Exactech, Inc. · Oct 2023
Vantage® Total Ankle System
K232002 · Exactech, Inc. · Sep 2023