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510(k) K241597

Freedom® Total Knee System - Porous Tibial Base Plate by Maxx Orthopedics, Inc. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2025
Date Received
June 3, 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 Maxx Orthopedics, Inc.

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  • K252777 — Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (October 31, 2025)
  • K253314 — Freedom Infinia™ Total Knee System (October 29, 2025)
  • K253144 — Freedom® Total Knee System – Titan PCK Components (October 22, 2025)
  • K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip) (August 25, 2025)
  • K251717 — Freedom® Total Knee System – Titanium Tibial Base Plate (June 26, 2025)
  • K250382 — Freedom Total Knee System (All-poly Tibial Plate) (March 13, 2025)
  • K243277 — Freedom® Medial Congruent Liner (November 19, 2024)
  • K240863 — Freedom® Total Knee System (July 2, 2024)
  • K200912 — Freedom(R) - TiNbN Coated Knee (November 18, 2020)

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)