ClearanceBrief
Company

Waldemar Link GmbH & Co. KG (Mfg Site)

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

0510(k) clearances (0 in 12 months)
65recalls (17 in 12 months)
58recalls that name a 510(k)

Product codes

CodeDeviceRecords
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer19
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer16
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented15
JDGProsthesis, Hip, Femoral Component, Cemented, Metal6
HTWBit, Drill4
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2
FZXGuide, Surgical, Instrument1
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1
LXHOrthopedic Manual Surgical Instrument1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 11, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Open, Classified
KROK143179
Mar 27, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Open, Classified
HTWNone listed
Mar 27, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Open, Classified
HTWNone listed
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Open, Classified
KROK151008
Dec 9, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
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.
Open, Classified
KROK151008
Sep 8, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Open, Classified
JWHK202924
Aug 11, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Open, Classified
JDGNone listed
Aug 11, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Open, Classified
JDGK953653
Apr 30, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-
Open, Classified
JWHK202924
Apr 30, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5)
Open, Classified
JWHK202924
Apr 30, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5)
Open, Classified
JWHK202924
Apr 30, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 88
Open, Classified
JWHK202924
Mar 17, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Open, Classified
JWHK202924
Mar 17, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
Open, Classified
JWHK202924
Mar 17, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Open, Classified
JWHK202924
Dec 26, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
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
Open, Classified
LZOK142187
Jul 18, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial
Open, Classified
JWHK143179
K151008 +1
Jul 18, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
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
Open, Classified
JWHK143179
K151008 +1
Mar 14, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Open, Classified
JDGK953653
Mar 14, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Open, Classified
JDGK953653
Mar 14, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
Open, Classified
JDGK953653
Mar 14, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
Open, Classified
JDGK953653
Mar 6, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
Embrace Drill Tower, Standard/Lateral (25mm)
Open, Classified
HTWNone listed
Mar 6, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
Embrace Drill Tower, Wedged (25mm)
Open, Classified
HTWNone listed
Feb 29, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
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:
Open, Classified
LZOK190535
Jan 18, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
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
Open, Classified
FZXNone listed
Sep 26, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
Open, Classified
LPHK200607
Aug 29, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
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
Open, Classified
LXHNone listed
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-121/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-120/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-117/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
Open, Classified
LZOK183141

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