Cleared Traditional

UNIVATION

K131167 · Aesculap Implant Systems, LLC · Orthopedic

Oct 2013

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K131167 is an FDA 510(k) clearance for the UNIVATION, a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HRY), submitted by Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on October 17, 2013, 176 days after receiving the submission on April 24, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3530.

Submission Details

510(k) Number	K131167 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2013
Decision Date	October 17, 2013
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3530