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FDA 510(k)

Balanced Knee System TriMax Porous Femoral Components

K-Number: K253161 · 2025-12-19

ApplicantOrtho Development Corp.
Decision Date2025-12-19
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Balanced Knee System TriMax Porous Femoral Components is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K253161. 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 Balanced Knee System TriMax Porous Femoral Components?

Balanced Knee System TriMax Porous Femoral Components is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Ortho Development Corp.. The 510(k) number is K253161.

When did Balanced Knee System TriMax Porous Femoral Components receive FDA 510(k) clearance?

Balanced Knee System TriMax Porous Femoral Components received FDA 510(k) clearance on 2025-12-19, under 510(k) number K253161.

Who is the listed applicant for Balanced Knee System TriMax Porous Femoral Components?

The FDA 510(k) record lists Ortho Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Balanced Knee System TriMax Porous Femoral Components?

The FDA product code for Balanced Knee System TriMax Porous Femoral Components is MBH.

Related Clinical Trials

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NCT03720782Safety and Performance Study of the Legion Porous System in Total Knee ArthroplastyACTIVE_NOT_RECRUITING

Other records listing Ortho Development Corp. as applicant

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K251052Trivicta® Hip StemK242984BKS Revision SystemK242833Legend® Acetabular ShellK233758Trivicta™ Hip StemK233093Balanced Knee® System TriMax PS Plus Tibial InsertK211086The Progen™ Trochanteric Nail System

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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.K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.

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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