# K151008: Link® Megasystem-C®

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Aug 26, 2015 after 133 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K023087 (2002). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023087: Global Modular Replacement System (GMRS), Howmedica Osteonics Corp. (2002) Summary page 5.

## Most influential descendants
- K220628: LINK Endo-Model EVO Knee System (2022), 0 descendants of its own
- K213675: MP Reconstruction System (2022), 0 descendants of its own
- K211768: LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE (2021), 0 descendants of its own
- K190181: Instruments for LINK MEGASYSTEM-C Family (2019), 0 descendants of its own

## Recalls of this device
- Jan 12, 2026 · Class II · Z-1521-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Jan 12, 2026 · Class II · Z-1517-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Jan 12, 2026 · Class II · Z-1522-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Jan 12, 2026 · Class II · Z-1514-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Jan 12, 2026 · Class II · Z-1519-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Jan 12, 2026 · Class II · Z-1516-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Jan 12, 2026 · Class II · Z-1513-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Jan 12, 2026 · Class II · Z-1511-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Jan 12, 2026 · Class II · Z-1520-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Jan 12, 2026 · Class II · Z-1512-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Jan 12, 2026 · Class II · Z-1515-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Jan 12, 2026 · Class II · Z-1518-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Jan 12, 2026 · Class II · Z-1523-2026: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Nov 10, 2025 · Class II · Z-0890-2026: The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
- May 22, 2024 · Class II · Z-2410-2024: Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
- May 22, 2024 · Class II · Z-2411-2024: Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

## Indications for use
The LINK® MEGASYSTEM-C® is intended to be used with the components of the Endo-Model® SL® Rotating and Non-Rotating Hinge Knee or Endo-Model® Knee System (#K143179) which can be integrated for knee joint replacement and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement. The LINK® MEGASYSTEM-C® is indicated for treatment of any of the following Limb salvage/Oncology procedures: 1) Revision for loosened femoral prosthesis components involving extensive bone loss; 2) Surgical intervention for severe trauma; 3) Oncology cases where extensive resection and replacement of bone is required from tibia to hip area; The device is to be used with bone cement unless a proximal femur or a modular stem is indicated for use. For the use of the LINK® Endo-Model® SL® Rotating and Non-Rotating Hinge Knee System additional indications should be noted: 1) Bone necroses. 2) Bicondylar arthrosis by partly damaged collateral ligaments. 3) Revision after primary total knee replacement. 4) Revision surgery after hinge knee or rotational knee joint. 5) Revision surgery by insufficient / inadequate bone mass. 6) Arthrosis of patella flange. 7) Valgus/Varus deformities <10°. 8) Valgus/Varus deformities 10-15°. 9) Valgus/Varus deformities 15-20°. For the use of the LINK® Endo-Model® SL® Non-Rotating Hinge Knee System additional indications should be noted: 10) Bicondylar arthrosis by completely damaged collateral ligaments and muscular instability. 11) Valgus/Varus deformities 20-30°.

Source page: https://510kreport.com/device/K151008
Methodology: https://510kreport.com/methodology