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
| Code | Device | Records |
|---|---|---|
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 19 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 16 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 15 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 6 |
| HTW | Bit, Drill | 4 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 |
| FZX | Guide, Surgical, Instrument | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2026 | Waldemar 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 |
KRO | K143179 |
| Mar 27, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Embrace Drill Tower, Standard/Lateral (25mm);
Item Number: 645-081/63; Open, Classified |
HTW | None listed |
| Mar 27, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Embrace Drill Tower, Wedged (25mm);
Item Number: 645-081/62; Open, Classified |
HTW | None listed |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-0027/16; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-0027/12; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-0027/11; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-8521/15; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-8521/11; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-8521/09; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-8030/12; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-2836/11; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-2835/12; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model SL Connection Component incl. PE-Plateau;
Item Number: 16-2840/07; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model SL Connection Component incl. PE-Plateau;
Item Number: 16-2840/02; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-0027/15; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model SL Connection Component incl. PE-Plateau;
Item Number: 16-2840/05; Open, Classified |
KRO | K151008 |
| Dec 9, 2025 | Waldemar 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 |
KRO | K151008 |
| Sep 8, 2025 | Waldemar 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 |
JWH | K202924 |
| Aug 11, 2025 | Waldemar Link GmbH & Co. KG (Mfg Site) Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15. Open, Classified |
JDG | None listed |
| Aug 11, 2025 | Waldemar Link GmbH & Co. KG (Mfg Site) Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. Open, Classified |
JDG | K953653 |
| Apr 30, 2025 | Waldemar 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 |
JWH | K202924 |
| Apr 30, 2025 | Waldemar 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 |
JWH | K202924 |
| Apr 30, 2025 | Waldemar 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 |
JWH | K202924 |
| Apr 30, 2025 | Waldemar 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 |
JWH | K202924 |
| Mar 17, 2025 | Waldemar 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 |
JWH | K202924 |
| Mar 17, 2025 | Waldemar 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 |
JWH | K202924 |
| Mar 17, 2025 | Waldemar 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 |
JWH | K202924 |
| Dec 26, 2024 | Waldemar 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 |
LZO | K142187 |
| Jul 18, 2024 | Waldemar 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 |
JWH | K143179 K151008 +1 |
| Jul 18, 2024 | Waldemar 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 |
JWH | K143179 K151008 +1 |
| Mar 14, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented Open, Classified |
JDG | K953653 |
| Mar 14, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented Open, Classified |
JDG | K953653 |
| Mar 14, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented Open, Classified |
JDG | K953653 |
| Mar 14, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented Open, Classified |
JDG | K953653 |
| Mar 6, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) Embrace Drill Tower, Standard/Lateral (25mm) Open, Classified |
HTW | None listed |
| Mar 6, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) Embrace Drill Tower, Wedged (25mm) Open, Classified |
HTW | None listed |
| Feb 29, 2024 | Waldemar 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 |
LZO | K190535 |
| Jan 18, 2024 | Waldemar 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 |
FZX | None listed |
| Sep 26, 2023 | Waldemar 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 |
LPH | K200607 |
| Aug 29, 2023 | Waldemar 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 |
LXH | None listed |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
Newest 50 of 65.