Cleared Traditional

The INBONE? Total Ankle System, the INFINITY? Total Ankle System and the INVISION? Total Ankle Revision System

K193067 · Wrightmedicaltechnologyinc · Orthopedic

Jun 2020

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K193067 is an FDA 510(k) clearance for the The INBONE? Total Ankle System, the INFINITY? Total Ankle System and 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 June 8, 2020, 217 days after receiving the submission on November 4, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K193067 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 2019
Decision Date	June 08, 2020
Days to Decision	217 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