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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 a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2016-11-03 under approval 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. It is manufactured by Biomet, Inc.. The 510(k) number is K161592.

When was Persona Partial Knee System approved by the FDA?

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

What company makes Persona Partial Knee System?

Persona Partial Knee System is manufactured by Biomet, Inc..

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

NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED NCT06467955 MagDI Canada Study ACTIVE_NOT_RECRUITING NCT06473831 MagDI Australia Study ACTIVE_NOT_RECRUITING NCT06613711 MagDI Italian Study COMPLETED NCT03073941 A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen ACTIVE_NOT_RECRUITING

Other Devices by Biomet, Inc.

K162424Ulna Plating System K161166StageOne Select Cement Spacer Molds for Temporary Hip Replacement K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis K161190G7 Dual Mobility System, Active Articulation System K153657Vanguard XP Knee System K160058Biomet Variable Pitch Compression Screw System

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Related Devices (Code: HSX)

K161060Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc. K160738ZUK Select Knee SystemSmith & Nephew, Inc. K172650Materialise PKA Guide SystemMaterialise NV K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. K161741GMK UNIMedacta International S.A. K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, 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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