The LINK® Endo-Model® Knee System— 510(k) K143179
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K143179 for The LINK® Endo-Model® Knee System, Substantially Equivalent on 2015-01-30. Applicant: Waldemar Link GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Waldemar Link GmbH & Co. KG
- Product code
- Code KRO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3510
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hamburg, DE
Recent devices under product code KRO
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- K231445 — LINK Embrace Shoulder System - Reverse Configuration
Adverse events under product code KRO
product code KRO- Death
- 19
- Injury
- 4,841
- Total
- 4,860
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K143179
K-number listed on FDA's recall record- Z-2934-2026 — Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
- Z-2410-2024 — 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, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33
- Z-2411-2024 — 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 Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm
- Z-2046-2023 — LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
- Z-2047-2023 — LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
- Z-2048-2023 — LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
- Z-2049-2023 — LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143179.
Data sourced from openFDA. This site is unofficial and independent of the FDA.