Cleared Traditional

BALANCED KNEE SYSTEM HIGH FLEX PS

K123457 · Ortho Development Corp. · Orthopedic

Mar 2013

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K123457 is an FDA 510(k) clearance for the BALANCED KNEE SYSTEM HIGH FLEX PS, 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 March 22, 2013, 134 days after receiving the submission on November 8, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K123457 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 2012
Decision Date	March 22, 2013
Days to Decision	134 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