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510(k) K243634

Maxx Libertas Bipolar Hip Head (Bipolar Hip) by Maxx Orthopedics, Inc. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2025
Date Received
November 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
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)
  • 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 KWY

  • K231526 — CORAIL Cemented Femoral Stem (December 19, 2023)
  • K223441 — SpaceFlex Acetabular Cup (March 23, 2023)
  • K221794 — Vario-Cup System (July 20, 2022)
  • K220492 — COPAL exchange G hip spacer (March 23, 2022)
  • K200709 — Kyocera Bipolar Hip System (April 17, 2020)
  • K192236 — Fitmore Hip Stem (November 5, 2019)
  • K191016 — COPAL exchange G Hip and Knee Spacers (November 1, 2019)
  • K191297 — iNSitu Bipolar Hip System (September 17, 2019)
  • K191569 — Implantcast ic-Bipolar Head System (August 28, 2019)
  • K183114 — Corin BiPolar-i (June 5, 2019)