Cleared Traditional

K181557 - INFINITY Total Ankle System

K181557 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 57-day FDA review.

K181557 · Wrightmedicaltechnologyinc · Orthopedic device
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Aug 2018
Decision
57d
Days
Class 2
Risk

K181557 is an FDA 510(k) clearance for the INFINITY 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 9, 2018 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K181557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2018
Decision Date August 09, 2018
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 K181557.
INFINITY Total Ankle System, INBONE Total Ankle System
K191393 · Wrightmedicaltechnologyinc · Aug 2019
Vantage Total Ankle Flat Cut Talar Components
K183343 · Exactech, Inc. · Apr 2019
Integra Salto Total Ankle System
K182878 · Ascension Orthopedics · Dec 2018
INVISION Total Ankle Revision System
K180730 · Wrightmedicaltechnologyinc · Jul 2018
INFINITY Total Ankle System
K172633 · Wrightmedicaltechnologyinc · Apr 2018
INVISION Total Ankle Revision System
K171067 · Wrightmedicaltechnologyinc · Sep 2017