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FDA 510(k)

MOTO Partial Knee System

K-Number: K183029 · 2019-01-30

ApplicantMedacta International S.A.
Decision Date2019-01-30
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MOTO Partial Knee System is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2019-01-30 under approval number K183029. 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?

MOTO Partial Knee System is a medical device that received FDA 510(k) clearance on 2019-01-30. It is manufactured by Medacta International S.A.. The 510(k) number is K183029.

When was MOTO Partial Knee System approved by the FDA?

MOTO Partial Knee System received FDA 510(k) clearance on 2019-01-30, under approval number K183029.

What company makes MOTO Partial Knee System?

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

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

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

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Related PubMed Literature

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Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

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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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