Cleared Traditional

Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts

K152169 · Ortho Development Corporation · Orthopedic

Oct 2015

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K152169 is an FDA 510(k) clearance for the Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on October 27, 2015, 84 days after receiving the submission on August 4, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K152169 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2015
Decision Date	October 27, 2015
Days to Decision	84 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