Cleared Traditional

PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT

K063211 · Stelkast Company · Orthopedic

Jan 2007

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K063211 is an FDA 510(k) clearance for the PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Stelkast Company (Mcmurray, US). The FDA issued a Cleared decision on January 18, 2007, 87 days after receiving the submission on October 23, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K063211 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 23, 2006
Decision Date	January 18, 2007
Days to Decision	87 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