Cleared Traditional

K191393 - INFINITY Total Ankle System

K191393 is the FDA 510(k) clearance for INFINITY Total Ankle System by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code HSN) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K191393 · Wrightmedicaltechnologyinc · Orthopedic device
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Aug 2019
Decision
90d
Days
Class 2
Risk

K191393 is an FDA 510(k) clearance for the INFINITY Total Ankle System, INBONE Total Ankle System. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on August 22, 2019 after a review of 90 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K191393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2019
Decision Date August 22, 2019
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 58
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K191393.
Cadence Total Ankle System
K201507 · Integra LifeSciences Corporation · Jun 2020
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
K193067 · Wrightmedicaltechnologyinc · Jun 2020
Quantum® Total Ankle Prosthesis
K191380 · In2bones Sas · Jan 2020
Vantage Total Ankle Flat Cut Talar Components
K183343 · Exactech, Inc. · Apr 2019
Integra Salto Total Ankle System
K182878 · Ascension Orthopedics · Dec 2018
INFINITY Total Ankle System
K181557 · Wrightmedicaltechnologyinc · Aug 2018