Cleared Traditional

K191393 - INFINITY Total Ankle System, INBONE Total Ankle System

K191393 is an FDA 510(k) clearance for INFINITY Total Ankle System, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K191393

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.

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 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