Cleared Traditional

INFINITY Total Ankle System

K181557 · Wrightmedicaltechnologyinc · Orthopedic

Aug 2018

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K181557 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 August 9, 2018, 57 days after receiving the submission on June 13, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K181557 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2018
Decision Date	August 09, 2018
Days to Decision	57 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