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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 a medical device manufactured by Ortho Development Corp.. It received FDA 510(k) clearance on 2025-12-19 under approval 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. It is manufactured by Ortho Development Corp.. The 510(k) number is K253161.

When was Balanced Knee System TriMax Porous Femoral Components approved by the FDA?

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

What company makes Balanced Knee System TriMax Porous Femoral Components?

Balanced Knee System TriMax Porous Femoral Components is manufactured by Ortho Development Corp..

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.

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Related Devices (Code: MBH)

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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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