Cleared Traditional

INVISION Total Ankle Revision System

K180730 · Wrightmedicaltechnologyinc · Orthopedic

Jul 2018

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K180730 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 July 11, 2018, 113 days after receiving the submission on March 20, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K180730 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2018
Decision Date	July 11, 2018
Days to Decision	113 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