Atlas FDA

LINK® MEGASYSTEM-C®

FDA 510(k) clearance K151008 · decided 2015-08-26

Clearance details

K-number
K151008
Device name
LINK® MEGASYSTEM-C®
Applicant
Waldemar Link GmbH & Co. KG
Decision
Substantially Equivalent
Date received
2015-04-15
Decision date
2015-08-26
Days to decision
133 days
Clearance type
Traditional
Product code
KRO
Device class
2
Regulation number
888.3510
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Hamburg, DE
Third-party review
No
Expedited review
No

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Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (K261898)Howmedica Osteonics Corp. dba Stryker Orthopaedics2026-08-06
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ATTUNE™ Revision Hinge Knee (K242871)Depuy Ireland UC2024-11-21
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ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (K233980)Depuy Ireland UC2024-03-21
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Recalls involving this device

RecordFirmDate
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; recall (Z-1511-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-0027/15; recall (Z-1512-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; recall (Z-1513-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; recall (Z-1514-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-2835/12; recall (Z-1515-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-2836/11; recall (Z-1516-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-8030/12; recall (Z-1517-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-8521/09; recall (Z-1518-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-8521/11; recall (Z-1519-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-8521/15; recall (Z-1520-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-0027/11; recall (Z-1521-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-0027/12; recall (Z-1522-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-0027/16; recall (Z-1523-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 6 recall (Z-0890-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2025-12-09
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 1 recall (Z-2410-2024)Waldemar Link GmbH & Co. KG (Mfg Site)2024-07-18
Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tib recall (Z-2411-2024)Waldemar Link GmbH & Co. KG (Mfg Site)2024-07-18