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Stelkast Co

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
43
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0970-2015Class IIEXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended foDecember 1, 2014
Z-2136-2013Class IISC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrJune 24, 2013
Z-1066-2013Class IIStelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459January 24, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K190276Provident II Hip StemMarch 8, 2019
K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertJanuary 19, 2018
K162222GENflex2 Total Knee SystemSeptember 7, 2016
K122883EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEMAugust 5, 2013
K122773CROSS-OVER ACETABULAR SHELL & LINEROctober 9, 2012
K094035EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MMMarch 24, 2011
K081458PROVEN STEM EXTENDERJune 6, 2008
K063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERTJanuary 18, 2007
K051976PROVEN REVISION MODULAR TIBIAL TRAYOctober 17, 2005
K033944STELKAST 32MM MODULAR CERAMIC FEMORAL HEADMarch 12, 2004
K032824STELKAST UNICONDYLAR KNEE SYSTEMNovember 13, 2003
K031901PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERTOctober 10, 2003
K032110PROCLASS PRESS FIT HIP STEMSeptember 22, 2003
K030577PROVEN MODULAR TIBIAL TRAYMarch 25, 2003
K021908PROVEN MODULAR POSTERIOR STABILIZED FEMORALJuly 9, 2002
K014049EPOCA CODR STEM AND HEADJanuary 9, 2002
K010282LATERAL OFFSET PROTRACT PRESS FIT HIP STEMFebruary 9, 2001
K010241PROTRACT PRESS FIT HIP STEM-HA COATEDFebruary 8, 2001
K003447PROTRACT PRESS FIT HIP STEMDecember 15, 2000
K002796MODIFICATION TO PROVIDENT HIP SYSTEMSeptember 28, 2000