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510(k) K000003

TORNIER TOTAL ELBOW PROSTHESIS by Tornier — Product Code JDC

K000003 is an FDA 510(k) premarket notification submitted by Tornier for the device "TORNIER TOTAL ELBOW PROSTHESIS". The FDA issued a decision of Substantially Equivalent on October 2, 2000. The device falls under product code JDC (Prosthesis, Elbow, Constrained, Cemented), a Class II device regulated under 21 CFR 888.3150. Tornier has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2000
Date Received
January 3, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Constrained, Cemented
Device Class
Class II
Regulation Number
888.3150
Review Panel
OR
Submission Type

Other clearances by Tornier

  • K252788 — Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) (January 8, 2026)
  • K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max) (October 30, 2025)
  • K232265 — BLUEPRINT™ Patient Specific Instrumentation (February 21, 2024)
  • K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail (October 31, 2023)
  • K222510 — Blueprint Mixed Reality system (January 20, 2023)
  • DEN220012 — Tornier Pyrocarbon Humeral Head (December 16, 2022)
  • K220914 — Tornier Perform Humeral System – Fracture (October 14, 2022)
  • K220418 — Tornier Perform Humeral System – Stemless (September 14, 2022)
  • K211359 — Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient (November 12, 2021)
  • K213124 — Tomier Perform™ Reversed Glenoid Cannulated Glenospheres (October 26, 2021)

Other clearances for product code JDC

  • K181362 — TEMA Elbow System (February 16, 2019)
  • K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow (January 28, 2019)
  • K153398 — Comprehensive SRS/Nexel Elbow (February 3, 2016)
  • K150501 — Zimmer Nexel Total Elbow Ulnar Cement Diverter (April 23, 2015)
  • K123862 — ZIMMER NEXEL TOTAL ELBOW (March 12, 2013)
  • K090473 — DISCOVERY ELBOW - X-SMALL (March 25, 2009)
  • K060696 — ACCLAIM TOTAL ELBOW SYSTEM (April 14, 2006)
  • K053189 — COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES (December 9, 2005)
  • K051975 — POROUS COATED DISCOVERY ELBOW (September 6, 2005)
  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)

FDA data resources