ClearanceBrief
Company · DE

Waldemar Link GmbH & Co. KG

FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2026. Name variants (Inc, Corp, punctuation) are merged.

43510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented11
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer5
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented3
PHXShoulder Prosthesis, Reverse Configuration3
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2
KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2
KXAProsthesis, Hip, Femoral, Resurfacing2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2
FTMMesh, Surgical1
HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented1
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 6, 2026K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)
Waldemar Link GmbH & Co. KG, DE
LZO
Nov 5, 2025K250375Allure Hip Stem and Intramedullary Plugs
Waldemar Link GmbH & Co. KG, DE
MEH
May 16, 2025K243927MobileLink Acetabular Cup System - inhouse coatings
Waldemar Link GmbH & Co. KG, DE
LZO
Nov 8, 2024K241636MobileLink Acetabular Cup System - Line Extension (Multiple)
Waldemar Link GmbH & Co. KG, DE
LPH
Nov 16, 2023K231445LINK Embrace Shoulder System - Reverse Configuration
Waldemar Link GmbH & Co. KG, DE
PHX
Apr 14, 2023K222066LINK MobileLink Acetabular Cup System
Waldemar Link GmbH & Co. KG, DE
LPH
Mar 21, 2023K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface
Waldemar Link GmbH & Co. KG, DE
JWH
Sep 13, 2022K213770SP-CL Hip Stem and LCU Hip System
Waldemar Link GmbH & Co. KG, DE
LZO
Jul 20, 2022K221794Vario-Cup System
Waldemar Link GmbH & Co. KG, DE
KWY
Jun 3, 2022K211567BiMobile Instruments (for BiMobile Dual Mobility System)
Waldemar Link GmbH & Co. KG, DE
LZO
May 3, 2022K220628LINK Endo-Model EVO Knee System
Waldemar Link GmbH & Co. KG, DE
KRO
Apr 11, 2022K213675MP Reconstruction System
Waldemar Link GmbH & Co. KG, DE
LZO
Nov 18, 2021K212992LINK® Embrace Shoulder System - Reverse Configuration
Waldemar Link GmbH & Co. KG, DE
PHX
Sep 16, 2021K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating
Waldemar Link GmbH & Co. KG, DE
JWH
Jun 30, 2021K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
Waldemar Link GmbH & Co. KG, DE
KRO
Jun 21, 2021K210899LINK Embrace Shoulder System- Anatomical Configuration
Waldemar Link GmbH & Co. KG, DE
KWT
May 28, 2021K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters
Waldemar Link GmbH & Co. KG, DE
LPH
May 13, 2021K202924LinkSymphoKnee System
Waldemar Link GmbH & Co. KG, DE
JWH
Feb 5, 2021K200368LINK Embrace Shoulder System - Reverse Configuration
Waldemar Link GmbH & Co. KG, DE
PHX
Jul 17, 2020K201364LINK TrabecuLink Femoral Cones
Waldemar Link GmbH & Co. KG, DE
MBH
Mar 18, 2020K200113LINK TrabecuLink Tibial Cones
Waldemar Link GmbH & Co. KG, DE
MBH
Dec 21, 2019K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)
Waldemar Link GmbH & Co. KG, DE
LZO
Aug 6, 2019K190535BiMobile Dual Mobility System - E-Dur Inserts
Waldemar Link GmbH & Co. KG, DE
LZO
Jul 18, 2019K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)
Waldemar Link GmbH & Co. KG, DE
JWH
May 24, 2019K182321MobileLink Acetabular Cup System
Waldemar Link GmbH & Co. KG, DE
LZO
Apr 3, 2019K182872LINK GEMINI SL Total Knee System
Waldemar Link GmbH & Co. KG, DE
JWH
Feb 8, 2019K183141LINK MP Monoblock Hip Prosthesis
Waldemar Link GmbH & Co. KG, DE
LZO
Jan 19, 2018K171273LINK® BiMobile(TM) Dual Mobility System
Waldemar Link GmbH & Co. KG, DE
MEH
Mar 16, 2017K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and
Waldemar Link GmbH & Co. KG, DE
LZO
May 9, 2016K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
Waldemar Link GmbH & Co. KG, DE
KRO
Aug 26, 2015K151008LINK® MEGASYSTEM-C®
Waldemar Link GmbH & Co. KG, DE
KRO
Jan 30, 2015K143179The LINK® Endo-Model® Knee System
Waldemar Link GmbH & Co. KG, DE
KRO
Nov 6, 2014K142187LINK MP RECONSTRUCTION PROSTHESIS
Waldemar Link GmbH & Co. KG, DE
LZO
Nov 18, 2005K051826BETACONE HIP PROSTHESIS SYSTEM
Waldemar Link GmbH & Co. KG
LWJ
Aug 13, 1985K852705LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS
Waldemar Link GmbH & Co. KG
JDI
Jun 3, 1985K843950LINK CEMENTLESS SCREW-IN ACETABULAR CUP
Waldemar Link GmbH & Co. KG
KWA
Jun 3, 1985K843940LINK CEMENTLESS SCREW-IN ACETABULAR CUP
Waldemar Link GmbH & Co. KG
KWA
Nov 14, 1984K844225LINK ACETABULAR MESH
Waldemar Link GmbH & Co. KG
FTM
Apr 21, 1980K800800PATELLAR COMPONENT FOR LUBINUS PATELLAR
Waldemar Link GmbH & Co. KG
HTG
Dec 5, 1979K792200TILLMAN HIP RESURFACING REPLACEMT PROS.
Waldemar Link GmbH & Co. KG
KXA
Mar 28, 1979K790488INTERPLANTA SP TOTAL HIP PROSTHESIS
Waldemar Link GmbH & Co. KG
JDI
Oct 24, 1978K781735ENDOPROSTHESIS SYSTEM, VARIO-HEAD
Waldemar Link GmbH & Co. KG
KWY
Sep 20, 1978K781490TILLMAN HIPSURFACE REPLACEMENT
Waldemar Link GmbH & Co. KG
KXA

Latest recalls

DateFirm and productCodeLinked 510(k)
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