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510(k) K240393

Exactech® TRULIANT® Knee System by Exactech, Inc. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2024
Date Received
February 8, 2024
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 Exactech, Inc.

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  • K243275 — Equinoxe® Scapula Fracture System (June 26, 2025)
  • K243839 — Alteon® HA Femoral Stems (March 10, 2025)
  • K233482 — Equinoxe® Central Screw Baseplate System (July 18, 2024)
  • K230717 — Exactech® Vantage® Total Ankle System (October 12, 2023)
  • K223933 — Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (September 25, 2023)
  • K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays (September 14, 2023)
  • K232002 — Vantage® Total Ankle System (September 11, 2023)
  • K223252 — TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (July 17, 2023)

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)