FDA 510(k)

ACS® LD FB Knee System

K-Number: K234044 · 2024-09-06

Decision Date2024-09-06

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ACS® LD FB Knee System is a medical device manufactured by Implantcast GmbH. It received FDA 510(k) clearance on 2024-09-06 under approval number K234044. 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 ACS® LD FB Knee System?

ACS® LD FB Knee System is a medical device that received FDA 510(k) clearance on 2024-09-06. It is manufactured by Implantcast GmbH. The 510(k) number is K234044.

When was ACS® LD FB Knee System approved by the FDA?

ACS® LD FB Knee System received FDA 510(k) clearance on 2024-09-06, under approval number K234044.

What company makes ACS® LD FB Knee System?

ACS® LD FB Knee System is manufactured by Implantcast GmbH.

What is the FDA product code for ACS® LD FB Knee System?

The FDA product code for ACS® LD FB Knee System is JWH.

Other Devices by Implantcast GmbH

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Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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.