Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System

• • Terminated Z-0970-2015 FDA Class II ·initiated 1 Dec 2014

  Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.

510(k) Number

K122883 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert

  Class II

  FDA 510(k) K173875 Active Cleared 19 Jan 2018

• Protract Press Fit Hip Stem

  Class II

  FDA 510(k) K003447 Active Cleared 15 Dec 2000

• Proform Cemented Femoral Component

  Class II

  FDA 510(k) K951083 Active Cleared 22 May 1995

• Dual Taper Wedge Pressed Fit Femoral Component

  Class II

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• Proven Knee System

  Class II

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• Stelkast Bipolar System

  Class II

  FDA 510(k) K972961 Active Cleared 4 Nov 1997

See all devices from Stelkast Company →