Stelkast Co
FDA Regulatory Profile
Stelkast Co appears in FDA public data with 3 recalls, 43 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0970-2015, Class II) was initiated on December 1, 2014. Its most recent 510(k) clearance was granted on March 8, 2019.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 43
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0970-2015 | Class II | EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended fo | December 1, 2014 |
| Z-2136-2013 | Class II | SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecr | June 24, 2013 |
| Z-1066-2013 | Class II | Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459 | January 24, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K190276 | Provident II Hip Stem | March 8, 2019 |
| K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert | January 19, 2018 |
| K162222 | GENflex2 Total Knee System | September 7, 2016 |
| K122883 | EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM | August 5, 2013 |
| K122773 | CROSS-OVER ACETABULAR SHELL & LINER | October 9, 2012 |
| K094035 | EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM | March 24, 2011 |
| K081458 | PROVEN STEM EXTENDER | June 6, 2008 |
| K063211 | PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT | January 18, 2007 |
| K051976 | PROVEN REVISION MODULAR TIBIAL TRAY | October 17, 2005 |
| K033944 | STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD | March 12, 2004 |
| K032824 | STELKAST UNICONDYLAR KNEE SYSTEM | November 13, 2003 |
| K031901 | PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT | October 10, 2003 |
| K032110 | PROCLASS PRESS FIT HIP STEM | September 22, 2003 |
| K030577 | PROVEN MODULAR TIBIAL TRAY | March 25, 2003 |
| K021908 | PROVEN MODULAR POSTERIOR STABILIZED FEMORAL | July 9, 2002 |
| K014049 | EPOCA CODR STEM AND HEAD | January 9, 2002 |
| K010282 | LATERAL OFFSET PROTRACT PRESS FIT HIP STEM | February 9, 2001 |
| K010241 | PROTRACT PRESS FIT HIP STEM-HA COATED | February 8, 2001 |
| K003447 | PROTRACT PRESS FIT HIP STEM | December 15, 2000 |
| K002796 | MODIFICATION TO PROVIDENT HIP SYSTEM | September 28, 2000 |