Cleared Traditional

UNITY TOATAL KNEE SYSTEM

K113060 · Corin USA · Orthopedic

Sep 2012

Decision

332d

Days

Class 2

Risk

About This 510(k) Submission

K113060 is an FDA 510(k) clearance for the UNITY TOATAL KNEE SYSTEM, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on September 10, 2012, 332 days after receiving the submission on October 14, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K113060 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 14, 2011
Decision Date	September 10, 2012
Days to Decision	332 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560