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510(k) K233507

EVOLUTION® Tibial Cones by Microport Orthopedics, Inc. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2024
Date Received
October 31, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type

Other clearances by Microport Orthopedics, Inc.

  • K250444 — NEXUS® Hip Stem (May 15, 2025)
  • K243574 — Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Techniqu (February 18, 2025)
  • K240046 — Ethylene Oxide Sterilization Supplier Change for MPO Hips (April 18, 2024)
  • K240452 — Ceramic Femoral Head (April 12, 2024)
  • K240043 — EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Fe (April 1, 2024)
  • K231947 — EVOLUTION® Cement Keel (October 31, 2023)
  • K230563 — EVOLUTION® Hinge Knee System (September 27, 2023)
  • K213817 — MPO Knee Instruments; MPO PROPHECY Knee Instruments (January 5, 2022)
  • K213816 — MPO Hip Instruments (January 5, 2022)
  • K200011 — E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS (October 1, 2021)

Other clearances for product code MBH

  • K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (March 9, 2026)
  • K253328 — GMK 3D Metal Tibial Tray Extension (February 26, 2026)
  • K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing I (February 18, 2026)
  • K253239 — Active-V Total Knee System; World Total Knee System (December 23, 2025)
  • K253161 — Balanced Knee System TriMax Porous Femoral Components (December 19, 2025)
  • K252777 — Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (October 31, 2025)
  • K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components (October 24, 2025)
  • K243656 — U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (July 31, 2025)
  • K250980 — Physica System (Physica CR Porous Femoral components) (May 22, 2025)
  • K243768 — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (March 27, 2025)