Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Waldemar Link GmbH & Co. KG — Predicate Candidate Screening
43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
102 daysmedian FDA review time
275 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | 2026-07-06 | 102 | 0 |
| K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | 2025-11-05 | 268 | 0 |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | 2025-05-16 | 147 | 0 |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | 2024-11-08 | 155 | 0 |
| K231445 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2023-11-16 | 182 | 0 |
| K222066 | LINK MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2023-04-14 | 275 | 0 |
| K230471 | LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articu | Waldemar Link GmbH & Co. KG | 2023-03-21 | 28 | 0 |
| K213770 | SP-CL Hip Stem and LCU Hip System | Waldemar Link GmbH & Co. KG | 2022-09-13 | 285 | 0 |
| K221794 | Vario-Cup System | Waldemar Link GmbH & Co. KG | 2022-07-20 | 29 | 0 |
| K211567 | BiMobile Instruments (for BiMobile Dual Mobility System) | Waldemar Link GmbH & Co. KG | 2022-06-03 | 378 | 0 |
| K220628 | LINK Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 2022-05-03 | 60 | 0 |
| K213675 | MP Reconstruction System | Waldemar Link GmbH & Co. KG | 2022-04-11 | 140 | 0 |
| K212992 | LINK® Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021-11-18 | 59 | 0 |
| K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sle | Waldemar Link GmbH & Co. KG | 2021-09-16 | 17 | 18 |
| K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UH | Waldemar Link GmbH & Co. KG | 2021-06-30 | 22 | 0 |
| K210899 | LINK Embrace Shoulder System- Anatomical Configuration | Waldemar Link GmbH & Co. KG | 2021-06-21 | 87 | 0 |
| K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liner | Waldemar Link GmbH & Co. KG | 2021-05-28 | 445 | 1 |
| K202924 | LinkSymphoKnee System | Waldemar Link GmbH & Co. KG | 2021-05-13 | 226 | 11 |
| K200368 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021-02-05 | 357 | 0 |
| K201364 | LINK TrabecuLink Femoral Cones | Waldemar Link GmbH & Co. KG | 2020-07-17 | 56 | 0 |
| K200113 | LINK TrabecuLink Tibial Cones | Waldemar Link GmbH & Co. KG | 2020-03-18 | 61 | 0 |
| K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2019-12-21 | 95 | 0 |
| K190535 | BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG | 2019-08-06 | 155 | 1 |
| K191755 | SPAR-K Instruments (for use with Gemini SL Total Knee System | Waldemar Link GmbH & Co. KG | 2019-07-18 | 17 | 0 |
| K182321 | MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2019-05-24 | 270 | 0 |
| K182872 | LINK GEMINI SL Total Knee System | Waldemar Link GmbH & Co. KG | 2019-04-03 | 173 | 0 |
| K183141 | LINK MP Monoblock Hip Prosthesis | Waldemar Link GmbH & Co. KG | 2019-02-08 | 87 | 12 |
| K171273 | LINK® BiMobile(TM) Dual Mobility System | Waldemar Link GmbH & Co. KG | 2018-01-19 | 263 | 0 |
| K161840 | LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP | Waldemar Link GmbH & Co. KG | 2017-03-16 | 254 | 0 |
| K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link | Waldemar Link GmbH & Co. KG | 2016-05-09 | 257 | 16 |
| K151008 | LINK® MEGASYSTEM-C® | Waldemar Link GmbH & Co. KG | 2015-08-26 | 133 | 16 |
| K143179 | The LINK® Endo-Model® Knee System | Waldemar Link GmbH & Co. KG | 2015-01-30 | 87 | 7 |
| K142187 | LINK MP RECONSTRUCTION PROSTHESIS | Waldemar Link GmbH & Co. KG | 2014-11-06 | 90 | 1 |
| K051826 | BETACONE HIP PROSTHESIS SYSTEM | Waldemar Link GmbH & Co. KG | 2005-11-18 | 136 | 0 |
| K852705 | LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS | Waldemar Link GmbH & Co. KG | 1985-08-13 | 48 | 0 |
| K843940 | LINK CEMENTLESS SCREW-IN ACETABULAR CUP | Waldemar Link GmbH & Co. KG | 1985-06-03 | 237 | 0 |
| K843950 | LINK CEMENTLESS SCREW-IN ACETABULAR CUP | Waldemar Link GmbH & Co. KG | 1985-06-03 | 237 | 0 |
| K844225 | LINK ACETABULAR MESH | Waldemar Link GmbH & Co. KG | 1984-11-14 | 13 | 0 |
| K800800 | PATELLAR COMPONENT FOR LUBINUS PATELLAR | Waldemar Link GmbH & Co. KG | 1980-04-21 | 11 | 0 |
| K792200 | TILLMAN HIP RESURFACING REPLACEMT PROS. | Waldemar Link GmbH & Co. KG | 1979-12-05 | 34 | 0 |
| K790488 | INTERPLANTA SP TOTAL HIP PROSTHESIS | Waldemar Link GmbH & Co. KG | 1979-03-28 | 16 | 0 |
| K781735 | ENDOPROSTHESIS SYSTEM, VARIO-HEAD | Waldemar Link GmbH & Co. KG | 1978-10-24 | 12 | 0 |
| K781490 | TILLMAN HIPSURFACE REPLACEMENT | Waldemar Link GmbH & Co. KG | 1978-09-20 | 23 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda