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FDA 510(k)

MobileLink Acetabular Cup System - inhouse coatings

K-Number: K243927 · 2025-05-16

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2025-05-16
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MobileLink Acetabular Cup System - inhouse coatings is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2025-05-16 under approval number K243927. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MobileLink Acetabular Cup System - inhouse coatings?

MobileLink Acetabular Cup System - inhouse coatings is a medical device that received FDA 510(k) clearance on 2025-05-16. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K243927.

When was MobileLink Acetabular Cup System - inhouse coatings approved by the FDA?

MobileLink Acetabular Cup System - inhouse coatings received FDA 510(k) clearance on 2025-05-16, under approval number K243927.

What company makes MobileLink Acetabular Cup System - inhouse coatings?

MobileLink Acetabular Cup System - inhouse coatings is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for MobileLink Acetabular Cup System - inhouse coatings?

The FDA product code for MobileLink Acetabular Cup System - inhouse coatings is LZO.

Related Clinical Trials

NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

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) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018)

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)

View all 29 devices →

Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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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