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510(k) K951083

PROFORM CEMENTED FEMORAL COMPONENT by Stelkast Company — Product Code JDG

K951083 is an FDA 510(k) premarket notification submitted by Stelkast Company for the device "PROFORM CEMENTED FEMORAL COMPONENT". The FDA issued a decision of SN on May 22, 1995. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Stelkast Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
May 22, 1995
Date Received
March 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class
Class II
Regulation Number
888.3360
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)
  • 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)

Other clearances for product code JDG

  • K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (February 7, 2022)
  • K193546 — Distal Centralizers (September 25, 2020)
  • K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (March 19, 2018)
  • K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT (September 27, 2000)
  • K992234 — THE TAPER-FIT TOTAL HIP SYSTEM (November 10, 1999)
  • K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM (August 8, 1996)
  • K955171 — NEXLOCK FEMORAL STEM (February 9, 1996)
  • K953653 — LUBINUS SP II HIP SYSTEM (November 6, 1995)
  • K953067 — HIP FRACTURE STEM FENESTRATION PLUG (August 21, 1995)
  • K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM (May 30, 1995)

FDA data resources