Data / Medical devices / Germany / Waldemar Link GmbH & Co. KG
Waldemar Link GmbH & Co. KG: FDA-registered device maker in Norderstedt Schleswig-Holstein, Germany, 42 510(k) clearances
Waldemar Link GmbH & Co. KG is registered with the FDA (registration 3004371426) in Norderstedt Schleswig-Holstein, Germany. It lists 68 device types. The FDA files 42 510(k) clearances under its listings, the newest dated July 6, 2026. 22 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3004371426
- FEI number
- 3003386935
- Address
- Oststrasse 4-10, Norderstedt Schleswig-Holstein, Germany, 22844
- Owner or operator
- WALDEMAR LINK GMBH & CO. KG (8010091)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 9, 1978
- Registered through
- 2027
- Brand names listed
- AC-POWERED MOTORED AND ACCESSORY / ATTACHMENT, Allure Hip Stem, Awl, BiMobile Dual Mobility System, BiMobile Dual Mobility System - E-Dur Inserts, BiMobile Instruments, Blade, Bone Chisel, Osteotome and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 6, 2026 | K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various) | LZO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| November 5, 2025 | K250375 | Allure Hip Stem and Intramedullary Plugs | MEH | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| May 16, 2025 | K243927 | MobileLink Acetabular Cup System - inhouse coatings | LZO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| November 8, 2024 | K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | LPH | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| November 16, 2023 | K231445 | LINK Embrace Shoulder System - Reverse Configuration | PHX | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| April 14, 2023 | K222066 | LINK MobileLink Acetabular Cup System | LPH | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| March 21, 2023 | K230471 | LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating Surface | JWH | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| September 13, 2022 | K213770 | SP-CL Hip Stem and LCU Hip System | LZO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| July 20, 2022 | K221794 | Vario-Cup System | KWY | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| June 3, 2022 | K211567 | BiMobile Instruments (for BiMobile Dual Mobility System) | LZO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| May 3, 2022 | K220628 | LINK Endo-Model EVO Knee System | KRO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| April 11, 2022 | K213675 | MP Reconstruction System | LZO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| November 18, 2021 | K212992 | LINK® Embrace Shoulder System - Reverse Configuration | PHX | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| September 16, 2021 | K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating | JWH | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| June 30, 2021 | K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | KRO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| June 21, 2021 | K210899 | LINK Embrace Shoulder System- Anatomical Configuration | KWT | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| May 28, 2021 | K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters | LPH | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| May 13, 2021 | K202924 | LinkSymphoKnee System | JWH | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| February 5, 2021 | K200368 | LINK Embrace Shoulder System - Reverse Configuration | PHX | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| July 17, 2020 | K201364 | LINK TrabecuLink Femoral Cones | MBH | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| March 18, 2020 | K200113 | LINK TrabecuLink Tibial Cones | MBH | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| December 21, 2019 | K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) | LZO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| August 6, 2019 | K190535 | BiMobile Dual Mobility System - E-Dur Inserts | LZO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| July 18, 2019 | K191755 | SPAR-K Instruments (for use with Gemini SL Total Knee System) | JWH | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| May 24, 2019 | K182321 | MobileLink Acetabular Cup System | LZO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| April 3, 2019 | K182872 | LINK GEMINI SL Total Knee System | JWH | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| February 8, 2019 | K183141 | LINK MP Monoblock Hip Prosthesis | LZO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| January 19, 2018 | K171273 | LINK® BiMobile(TM) Dual Mobility System | MEH | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| March 16, 2017 | K161840 | LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated | LZO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| May 9, 2016 | K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating | KRO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| August 26, 2015 | K151008 | LINK® MEGASYSTEM-C® | KRO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| January 30, 2015 | K143179 | The LINK® Endo-Model® Knee System | KRO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| November 6, 2014 | K142187 | LINK MP RECONSTRUCTION PROSTHESIS | LZO | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| February 14, 1996 | K955296 | LINK MP RECONSTRUCTION HIP | JDI | Substantially Equivalent | Link America, Inc. | accessdata.fda.gov |
| January 26, 1996 | K954186 | SLED UNICOMPARTMENT KNEE SYSTEM | HSX | Substantially Equivalent | Link America, Inc. | accessdata.fda.gov |
| November 6, 1995 | K953653 | LUBINUS SP II HIP SYSTEM | JDG | Substantially Equivalent | Turnkey Intergration USA, Inc. | accessdata.fda.gov |
| July 5, 1995 | K943986 | LINK ENDO MODEL REVISION CUP | HRS | Substantially Equivalent | Turnkey Intergration USA, Inc. | accessdata.fda.gov |
| April 19, 1994 | K931571 | LINK CERAMIC HEADS 12/14 X 32MM | LZO | Substantially Equivalent for Some Indications | Link America, Inc. | accessdata.fda.gov |
| May 18, 1992 | K920756 | FELDMUHLE CERAMIC HEAD | LZO | Substantially Equivalent | Link America, Inc. | accessdata.fda.gov |
| June 23, 1982 | K821476 | BARD ENDO LINK INTRACONDYLAR ROTATING | KRO | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 28, 1979 | K790488 | INTERPLANTA SP TOTAL HIP PROSTHESIS | JDI | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
| October 24, 1978 | K781735 | ENDOPROSTHESIS SYSTEM, VARIO-HEAD | KWY | Substantially Equivalent | Waldemar Link GmbH & Co. KG | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 6, 2026 | 99405 | Class II | Ongoing | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, | accessdata.fda.gov |
| February 11, 2026 | 98431 | Class II | Ongoing | Embrace Drill Tower, Wedged (25mm); Item Number: /62 | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. | accessdata.fda.gov |
| January 12, 2026 | 98342 | Class II | Ongoing | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05 | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | accessdata.fda.gov |
| November 10, 2025 | 97971 | Class II | Ongoing | Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices. | The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component. | accessdata.fda.gov |
| July 31, 2025 | 97383 | Class II | Ongoing | LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: /50 | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. | accessdata.fda.gov |
| July 15, 2025 | 97275 | Class II | Ongoing | Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: /04. | Inconsistent size terminology and color coding used on labeling | accessdata.fda.gov |
| April 3, 2025 | 96643 | Class II | Ongoing | Distal Femoral Augment; Item Numbers: (1) /11 (Sz. 0 - cemented sm), (2) /21 (Sz. 0 - cemented lg), (3) /11 (Sz. 1-2 - cemented sm), (4) /21 (Sz. 1-2 - cemented lg), (5) /11 (Sz. 3-4 - cemented sm), (6) /12 (Sz. 3-4 - ce | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | accessdata.fda.gov |
| February 14, 2025 | 96386 | Class II | Ongoing | Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: /11 | A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product. | accessdata.fda.gov |
| December 5, 2024 | 95933 | Class II | Ongoing | LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in pat | Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset). | accessdata.fda.gov |
| May 22, 2024 | 94814 | Class II | Ongoing | Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, | Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique | accessdata.fda.gov |
| February 6, 2024 | 94078 | Class II | Ongoing | SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery. | accessdata.fda.gov |
| January 29, 2024 | 93979 | Class II | Ongoing | Embrace Drill Tower, Wedged (25mm) | The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF /62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments. | accessdata.fda.gov |
| January 22, 2024 | 93944 | Class II | Ongoing | LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: /12 | Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery | accessdata.fda.gov |
| November 30, 2023 | 93662 | Class II | Ongoing | Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05 | Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time | accessdata.fda.gov |
| July 26, 2023 | 92839 | Class II | Ongoing | Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01 | A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery | accessdata.fda.gov |
| July 14, 2023 | 92807 | Class II | Ongoing | MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination | Product is labeled with incorrect offset. | accessdata.fda.gov |
| July 3, 2023 | 92758 | Class II | Ongoing | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: /00 | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | accessdata.fda.gov |
| December 23, 2022 | 92496 | Class II | Ongoing | LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: /11 | Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation). | accessdata.fda.gov |
| May 24, 2022 | 90477 | Class II | Ongoing | Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis. | There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure. | accessdata.fda.gov |
| March 18, 2021 | 92500 | Class II | Ongoing | LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right | The firm discovered through customer complaints that device segments may not meet specifications. | accessdata.fda.gov |
| December 7, 2018 | 81778 | Class II | Terminated | LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number /12 Product Usage: The LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTL | The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly. The correct fit of the neck can't be verif | accessdata.fda.gov |
| December 4, 2018 | 81762 | Class II | Terminated | BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number /02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative | The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records. | accessdata.fda.gov |
Compare with other makers
- All makers of Screwdriver
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- All makers of Awl
Updated August 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.