# K190181: Instruments for LINK MEGASYSTEM-C Family

- Pathway: 510(k) (Traditional)
- Applicant: LinkBio Corp.
- Decided: Oct 25, 2019 after 266 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945028 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151008: Link® Megasystem-C®, Waldemar Link GmbH & Co. KG (2015) Summary page 3.
- K143179: The LINK® Endo-Model® Knee System, Waldemar Link GmbH & Co. KG (2015) Summary page 3.
- K142187: Link MP Reconstruction Prosthesis, Waldemar Link GmbH & Co. KG (2014) Summary page 3.

## Indications for use
The Instruments for LINK MEGASYSTEM-C Family are intended to aid in intra-operative implantation of the LINK® MEGASYSTEM-C® (K151008), which can be integrated with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) for knee replacement, and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement. The LINK® MEGASYSTEM-C® (K151008), has the following indications: 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 surgery after primary total knee replacement. 4) Revision surgery after rotating or non-rotating hinged knee replacement. 5) Revision surgery by insufficient / inadequate bone mass. 6) Arthrosis of patella flange. 7) ValgusNarus deformities <10°. 8) ValgusNarus deformities 10-15°. 9) ValgusNarus 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 ligaments and muscular instability. 11) ValgusNarus deformities 20-30°.

Source page: https://510kreport.com/device/K190181
Methodology: https://510kreport.com/methodology