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FDA 510(k)

Arthrex iBalance Partial Knee System

K-Number: K251453 · 2025-07-01

ApplicantArthrex, Inc.
Decision Date2025-07-01
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex iBalance Partial Knee System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2025-07-01 under approval number K251453. 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 Arthrex iBalance Partial Knee System?

Arthrex iBalance Partial Knee System is a medical device that received FDA 510(k) clearance on 2025-07-01. It is manufactured by Arthrex, Inc.. The 510(k) number is K251453.

When was Arthrex iBalance Partial Knee System approved by the FDA?

Arthrex iBalance Partial Knee System received FDA 510(k) clearance on 2025-07-01, under approval number K251453.

What company makes Arthrex iBalance Partial Knee System?

Arthrex iBalance Partial Knee System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex iBalance Partial Knee System?

The FDA product code for Arthrex iBalance Partial Knee System is HSX.

Related Clinical Trials

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Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by Arthrex, Inc.

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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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