Home / 510(k) Clearances / K081458

510(k) K081458

PROVEN STEM EXTENDER by Stelkast Company — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2008
Date Received
May 23, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Other clearances by Stelkast Company

  • 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 SY (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)
  • 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)

Other clearances for product code JWH

  • K253793 — Materialise TKA Guide System (January 6, 2026)
  • K252974 — EMPOWR Knee (December 19, 2025)
  • K253197 — ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (November 19, 2025)
  • K253314 — Freedom Infinia™ Total Knee System (October 29, 2025)
  • K253144 — Freedom® Total Knee System – Titan PCK Components (October 22, 2025)
  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
  • K251554 — Materialise TKA Guide System (July 14, 2025)
  • K251776 — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (July 8, 2025)
  • K251241 — EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (July 2, 2025)
  • K251717 — Freedom® Total Knee System – Titanium Tibial Base Plate (June 26, 2025)