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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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2025-07-01 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K251453.

When did Arthrex iBalance Partial Knee System receive FDA 510(k) clearance?

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

Who is the listed applicant for Arthrex iBalance Partial Knee System?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07553975Randomized Arthrex Nano Arthroscopy in Arthroscopic ACL vs Conventional ArthroscopyNOT_YET_RECRUITING

Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: HSX)

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.

K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, 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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