510(k) K212742 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating
| Applicant | Waldemar Link GmbH & Co. KG, Norderstedt, DE |
| Decision | Substantially Equivalent, Sep 16, 2021 |
| Received | Aug 30, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212742
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO SLED KNEE FEM COMP, SMALL
Item Number: 15-2220/40 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL
Item Number: 15-2220/46 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO SLED KNEE FEM COMP, MEDIUM
Item Number: 15-2220/52 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO SLED KNEE FEM COMP, LARGE
Item Number: 15-2220/60 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM
Item Number: 15-2230/02 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM
Item Number: 15-2230/03 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM
Item Number: 15-2230/04 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM
Item Number: 15-2230/06 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM
Item Number: 15-2230/07 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM
Item Number: 15-2230/08 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM
Item Number: 15-2230/10 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM
Item Number: 15-2230/11 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM
Item Number: 15-2230/12 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM
Item Number: 15-2230/13 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM
Item Number: 15-2230/14 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM
Item Number: 15-2230/15 Open, Classified |
KRO | None listed |
| May 24, 2022 | Waldemar Link GmbH & Co. KG (Mfg Site) 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. Open, Classified |
JWH | None listed |
| May 24, 2022 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.:
X-Small, Right 15-3815/11,
Small, Right 15-3816/11,
Small, Left 15-3816/12,
Medium, Right 15-3 Open, Classified |
JWH | None listed |
| May 24, 2022 | Waldemar Link GmbH & Co. KG (Mfg Site) Tibial Component. orthopedic prosthesis. Model Nos:
Small, W 16-2817/02
Medium, W 16-2817/05
Large, W 16-2817/07 Open, Classified |
JWH | None listed |
| May 24, 2022 | Waldemar Link GmbH & Co. KG (Mfg Site) Tibial Component Modular. orthopedic prosthesis. Model Nos:
Small, W 16-2817/32
Medium, W 16-2817/35
Large, W 16-2817/37 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.