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FDA 510(k)

ACS® LD FB Knee System

K-Number: K234044 · 2024-09-06

ApplicantImplantcast GmbH
Decision Date2024-09-06
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACS® LD FB Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2024-09-06 under 510(k) 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. The listed applicant is Implantcast GmbH. The 510(k) number is K234044.

When did ACS® LD FB Knee System receive FDA 510(k) clearance?

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

Who is the listed applicant for ACS® LD FB Knee System?

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

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 records listing Implantcast GmbH 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.

K252451EPORE® XO cup systemK260037implantcast Packaging System UpdateK252401implaFit® short stemsK241944AGILON® XO Shoulder Replacement SystemK240391MUTARS® femoral stem cemented 160 mm and 200 mmK240834EcoFit® short stem cementless cpTi

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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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