Cleared Traditional

BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA

K131337 · Ortho Development Corp. · Orthopedic

Oct 2013

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K131337 is an FDA 510(k) clearance for the BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on October 11, 2013, 155 days after receiving the submission on May 9, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K131337 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2013
Decision Date	October 11, 2013
Days to Decision	155 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