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FDA 510(k)

ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System

K-Number: K240669 · 2024-06-20

ApplicantGlobus Medical, Inc.
Decision Date2024-06-20
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K240669. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System?

ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Globus Medical, Inc.. The 510(k) number is K240669.

When did ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System receive FDA 510(k) clearance?

ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System received FDA 510(k) clearance on 2024-06-20, under 510(k) number K240669.

Who is the listed applicant for ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System?

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

What is the FDA product code for ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System?

The FDA product code for ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System is JWH.

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Other records listing Globus Medical, Inc. as applicant

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K254043TRIVANCE™ Hip StemK262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ SystemK253401SCRIPT™ Implant SystemK261043AUTOBAHN™ Nailing SystemK252166RIB LINK™ Fixation System

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Related Devices (Code: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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