Cleared Traditional

INVISION Total Ankle Revision System

K171067 · Wrightmedicaltechnologyinc · Orthopedic

Sep 2017

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K171067 is an FDA 510(k) clearance for the INVISION Total Ankle Revision 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 September 11, 2017, 154 days after receiving the submission on April 10, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K171067 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2017
Decision Date	September 11, 2017
Days to Decision	154 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