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510(k) K202740

Klassic Knee System Tibial Inserts, PS-Max by Total Joint Orthopedics, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2020
Date Received
September 18, 2020
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 Total Joint Orthopedics, Inc.

  • K220483 — Platform® Acetabular System (September 23, 2022)
  • K211877 — Klassic Knee System (June 22, 2022)
  • K211602 — Klassic Knee System (July 23, 2021)
  • K183596 — Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS (March 29, 2019)
  • K190280 — Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - (March 15, 2019)
  • K180929 — Klassic HD® Hip System (May 9, 2018)
  • K180159 — Klassic® Knee System (March 9, 2018)
  • K173104 — Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile (October 27, 2017)
  • K162422 — Klassic Knee System (October 28, 2016)
  • K162256 — Klassic Femur, Porous, Klassic Tibial Baseplate, Porous (October 27, 2016)

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