Cleared Traditional

INFINITY Total Ankle System

K172633 · Wrightmedicaltechnologyinc · Orthopedic

Apr 2018

Decision

237d

Days

Class 2

Risk

About This 510(k) Submission

K172633 is an FDA 510(k) clearance for the INFINITY Total Ankle System, a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSN), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on April 26, 2018, 237 days after receiving the submission on September 1, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K172633 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 01, 2017
Decision Date	April 26, 2018
Days to Decision	237 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3110