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510(k) K252777

Freedom Metaphyseal Cone Implants (Metaphyseal Cones) by Maxx Orthopedics, Inc. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2025
Date Received
September 2, 2025
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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  • 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)
  • K241597 — Freedom® Total Knee System - Porous Tibial Base Plate (February 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

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  • 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)
  • 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)
  • K241597 — Freedom® Total Knee System - Porous Tibial Base Plate (February 13, 2025)