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510(k) K243991

Klassic Knee System - Revision Tibial Baseplate by Total Joint Othopedics, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2025
Date Received
December 26, 2024
Clearance Type
Traditional
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 Total Joint Othopedics, Inc.

  • K232414 — Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post (September 8, 2023)
  • K230537 — Klassic Knee Revision System (May 19, 2023)
  • K213580 — Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length (December 3, 2021)
  • K191399 — BIOLOX CONTOURA Ceramic Femoral Head (August 28, 2019)
  • K171962 — Klassic HD® Hip System (July 24, 2017)
  • K161073 — Klassic HD Hip System (October 19, 2016)
  • K143407 — Klassic HD Hip System (December 23, 2014)

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)