Cleared Traditional

BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM

K060569 · Ortho Development Corp. · Orthopedic

Jul 2006

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K060569 is an FDA 510(k) clearance for the BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM, 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 July 6, 2006, 125 days after receiving the submission on March 3, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K060569 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 2006
Decision Date	July 06, 2006
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

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