510(k) K143179 · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
The LINK® Endo-Model® Knee System
| Applicant | Waldemar Link GmbH & Co. KG, Hamburg, DE |
| Decision | Substantially Equivalent, Jan 30, 2015 |
| Received | Nov 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143179
| 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 | 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 |
| Jun 30, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right Open, Classified |
KRO | None listed |
| Jun 30, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left Open, Classified |
KRO | None listed |
| Jun 30, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right Open, Classified |
KRO | None listed |
| Jun 30, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left Open, Classified |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.