FDA.reportPublic FDA data

MobileLink Acetabular Cup System

Primary DI
04026575189014
Brand
MobileLink Acetabular Cup System
Company
WALDEMAR LINK GmbH & Co. KG
Model
183-762/36
Catalog number
183-762/36
Device description
UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset
Published
2025-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241636000MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG2024-11-08LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575189014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575189014040265751890144026575189014

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315675488
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04026575083237Endo-Model Knee System - EVO Knee System - OptiStem Instr151-16/16151-16/162026-05-15
04026575083282Endo-Model Knee System - EVO Knee System - OptiStem Instr151-17/17151-17/172026-05-15
04026575083329Endo-Model Knee System - EVO Knee System - OptiStem Instr151-18/18151-18/182026-05-15
04026575083404Endo-Model Knee System - EVO Knee System - OptiStem Instr151-19/19151-19/192026-05-15
04026575083503Endo-Model Knee System - EVO Knee System - OptiStem Instr151-20/20151-20/202026-05-15
04026575083640Endo-Model Knee System - EVO Knee System - OptiStem Instr151-21/21151-21/212026-05-15
04026575083732Endo-Model Knee System - EVO Knee System - OptiStem Instr151-04/04151-04/042026-05-15
04026575092307LinkSymphoKnee - Instruments151-09/09151-09/092026-05-15
04026575092321LinkSymphoKnee - Instruments151-10/10151-10/102026-05-15
04026575092345LinkSymphoKnee - Instruments151-11/11151-11/112026-05-15
04026575092352Endo-Model Knee System - EVO Knee System - OptiStem Instr151-12/12151-12/122026-05-15
04026575092437Endo-Model Knee System - EVO Knee System - OptiStem Instr151-13/13151-13/132026-05-15
04026575093014Endo-Model Knee System - EVO Knee System - OptiStem Instr151-14/14151-14/142026-05-15
04026575093021Endo-Model Knee System - EVO Knee System - OptiStem Instr151-15/15151-15/152026-05-15
04026575048168General Instrument15-80352026-02-02
04026575080106MP Reconstruction System Instruments134-011/002026-02-02
04026575080175MP Reconstruction System Instruments134-031/002026-02-02
04026575080182General Instrument134-210/002026-02-02
04026575081011MP Reconstruction System - Instruments134-212/002026-02-02
04026575081042MP Reconstruction System Instruments134-041/002026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07611996118674POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142327POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142334POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142341POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142358POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142372POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142396POLARSTEMSmith & Nephew, Inc.LZO2016-09-01
07611996142396POLARSTEMSmith & Nephew, Inc.MEH2016-09-01
07611996074918SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075007SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075038SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095586SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095593SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095609SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095616SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095623SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095630SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095647SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095654SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19