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FDA 510(k)

Agility Symmetric™ Total Knee System

K-Number: K242412 · 2024-11-06

ApplicantMedisurge, LLC
Decision Date2024-11-06
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Agility Symmetric™ Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Medisurge, LLC. It received FDA 510(k) clearance on 2024-11-06 under 510(k) number K242412. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Agility Symmetric™ Total Knee System?

Agility Symmetric™ Total Knee System is a medical device that received FDA 510(k) clearance on 2024-11-06. The listed applicant is Medisurge, LLC. The 510(k) number is K242412.

When did Agility Symmetric™ Total Knee System receive FDA 510(k) clearance?

Agility Symmetric™ Total Knee System received FDA 510(k) clearance on 2024-11-06, under 510(k) number K242412.

Who is the listed applicant for Agility Symmetric™ Total Knee System?

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

What is the FDA product code for Agility Symmetric™ Total Knee System?

The FDA product code for Agility Symmetric™ Total Knee System is MBH.

Related Devices (Code: MBH)

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.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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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