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FDA 510(k)

MOTO Partial Knee System Extension

K-Number: K251618 · 2025-07-24

ApplicantMedacta International S.A.
Decision Date2025-07-24
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MOTO Partial Knee System Extension is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2025-07-24 under approval number K251618. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOTO Partial Knee System Extension?

MOTO Partial Knee System Extension is a medical device that received FDA 510(k) clearance on 2025-07-24. It is manufactured by Medacta International S.A.. The 510(k) number is K251618.

When was MOTO Partial Knee System Extension approved by the FDA?

MOTO Partial Knee System Extension received FDA 510(k) clearance on 2025-07-24, under approval number K251618.

What company makes MOTO Partial Knee System Extension?

MOTO Partial Knee System Extension is manufactured by Medacta International S.A..

What is the FDA product code for MOTO Partial Knee System Extension?

The FDA product code for MOTO Partial Knee System Extension is HSX.

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Related PubMed Literature

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Related Devices (Code: HSX)

K161060Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc. K161592Persona Partial Knee SystemBiomet, Inc. K160738ZUK Select Knee SystemSmith & Nephew, Inc. K172650Materialise PKA Guide SystemMaterialise NV K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. K161741GMK UNIMedacta International S.A.

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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