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FDA 510(k)

Persona Partial Knee System

K-Number: K161592 · 2016-11-03

ApplicantBiomet, Inc.
Decision Date2016-11-03
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Persona Partial Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2016-11-03 under 510(k) number K161592. 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 Persona Partial Knee System?

Persona Partial Knee System is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Biomet, Inc.. The 510(k) number is K161592.

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

Persona Partial Knee System received FDA 510(k) clearance on 2016-11-03, under 510(k) number K161592.

Who is the listed applicant for Persona Partial Knee System?

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

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

The FDA product code for Persona 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.

NCT05391828Persona MC vs PS RCT With ROSARECRUITINGNCT06089291Persona IQ Cohort StudyACTIVE_NOT_RECRUITINGNCT03034811Persona Partial Knee Clinical Outcomes StudyACTIVE_NOT_RECRUITING

Other records listing Biomet, Inc. as applicant

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.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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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.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, 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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