Cleared Traditional

EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM

K122883 · Stelkast Company · Orthopedic

Aug 2013

Decision

319d

Days

Class 2

Risk

About This 510(k) Submission

K122883 is an FDA 510(k) clearance for the EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM, 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 August 5, 2013, 319 days after receiving the submission on September 20, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K122883 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2012
Decision Date	August 05, 2013
Days to Decision	319 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