Search Results

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 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) 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 ligaments and muscular instability. 11) Valgus/Varus deformities 20-30°.

The LINK® MEGASYSTEM-C® is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of LINK® Endo-Model® SL® Rotating and Non- Rotating Hinge Knee, LINK® Endo-Model® Knee System (#K143179) and LINK® MP® Reconstruction Prosthesis (#K142187). This is a duplicate 510k and line extension in Link Bio Corp.'s name for the accessory instrument system previously cleared in K151008 by Waldemar Link GmbH & Co KG for use with/as accessories to the LINK® MEGASYSTEM-C® and in conjunction with components of LINK® Endo-Model® SL® Rotating and Non- Rotating Hinge Knee, LINK® Endo-Model® Knee System (#K143179) and LINK® MP® Reconstruction Prosthesis (#K142187). It includes the same instruments as in K151008, and additional accessory instruments (line extension).