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FDA 510(k)

LINK TrabecuLink Femoral Cones

K-Number: K201364 · 2020-07-17

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2020-07-17
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK TrabecuLink Femoral Cones is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2020-07-17 under approval number K201364. 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 LINK TrabecuLink Femoral Cones?

LINK TrabecuLink Femoral Cones is a medical device that received FDA 510(k) clearance on 2020-07-17. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K201364.

When was LINK TrabecuLink Femoral Cones approved by the FDA?

LINK TrabecuLink Femoral Cones received FDA 510(k) clearance on 2020-07-17, under approval number K201364.

What company makes LINK TrabecuLink Femoral Cones?

LINK TrabecuLink Femoral Cones is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for LINK TrabecuLink Femoral Cones?

The FDA product code for LINK TrabecuLink Femoral Cones is MBH.

Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025)

Other Devices by Waldemar Link GmbH & Co. KG

K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated K171273LINK® BiMobile(TM) Dual Mobility System K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System) K190535BiMobile Dual Mobility System - E-Dur Inserts K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)

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Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, Inc.

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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