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FDA 510(k)

Freedom Metaphyseal Cone Implants (Metaphyseal Cones)

K-Number: K252777 · 2025-10-31

ApplicantMaxx Orthopedics, Inc.
Decision Date2025-10-31
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Freedom Metaphyseal Cone Implants (Metaphyseal Cones) is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2025-10-31 under 510(k) number K252777. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Freedom Metaphyseal Cone Implants (Metaphyseal Cones)?

Freedom Metaphyseal Cone Implants (Metaphyseal Cones) is a medical device that received FDA 510(k) clearance on 2025-10-31. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K252777.

When did Freedom Metaphyseal Cone Implants (Metaphyseal Cones) receive FDA 510(k) clearance?

Freedom Metaphyseal Cone Implants (Metaphyseal Cones) received FDA 510(k) clearance on 2025-10-31, under 510(k) number K252777.

Who is the listed applicant for Freedom Metaphyseal Cone Implants (Metaphyseal Cones)?

The FDA 510(k) record lists Maxx Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Freedom Metaphyseal Cone Implants (Metaphyseal Cones)?

The FDA product code for Freedom Metaphyseal Cone Implants (Metaphyseal Cones) is MBH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06627673MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar DesignRECRUITINGNCT06627699Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® SystemRECRUITING

Other records listing Maxx Orthopedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261563Freedom Total Knee System (E-Poly Tibial Liners)K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)K253314Freedom Infinia™ Total Knee SystemK253144Freedom® Total Knee System – Titan PCK ComponentsK243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)K251717Freedom® Total Knee System – Titanium Tibial Base Plate

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Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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