Cleared Traditional

INFINITY Total Ankle System, INBONE Total Ankle System

K191393 · Wrightmedicaltechnologyinc · Orthopedic

Aug 2019

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K191393 is an FDA 510(k) clearance for the INFINITY Total Ankle System, INBONE 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 August 22, 2019, 90 days after receiving the submission on May 24, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K191393 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2019
Decision Date	August 22, 2019
Days to Decision	90 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