510(k) K151008 · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
LINK® MEGASYSTEM-C®
| Applicant | Waldemar Link GmbH & Co. KG, Hamburg, DE |
| Decision | Substantially Equivalent, Aug 26, 2015 |
| Received | Apr 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-0027/15; Open, Classified |
KRO | None listed |
| 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 | None listed |
| 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 | None listed |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-2835/12; Open, Classified |
KRO | None listed |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-2836/11; Open, Classified |
KRO | None listed |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-8030/12; Open, Classified |
KRO | None listed |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-8521/09; Open, Classified |
KRO | None listed |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-8521/11; Open, Classified |
KRO | None listed |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-8521/15; Open, Classified |
KRO | None listed |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-0027/11; Open, Classified |
KRO | None listed |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-0027/12; Open, Classified |
KRO | None listed |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-0027/16; Open, Classified |
KRO | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.