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FDA 510(k)

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

K-Number: K230471 · 2023-03-21

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2023-03-21
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2023-03-21 under approval number K230471. 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 LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface?

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is a medical device that received FDA 510(k) clearance on 2023-03-21. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K230471.

When was LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface approved by the FDA?

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface received FDA 510(k) clearance on 2023-03-21, under approval number K230471.

What company makes LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface?

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface?

The FDA product code for LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is JWH.

Related Clinical Trials

NCT00435357 Comparison Between Fixed- Versus Mobile-bearing TKA COMPLETED NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT07286513 Persona SoluTion PPS Femur PMCF ENROLLING_BY_INVITATION

Other Devices by Waldemar Link GmbH & Co. KG

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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.

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