# K220628: LINK Endo-Model EVO Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: May 3, 2022 after 60 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: 7 generations back to K936079 (1994). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143179: The LINK® Endo-Model® Knee System, Waldemar Link GmbH & Co. KG (2015) Summary page 5.
- K152431: LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating, Waldemar Link GmbH & Co. KG (2016) Summary page 5.
- K212742: GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating, Waldemar Link GmbH & Co. KG (2021) Summary page 5.
- K202924: LinkSymphoKnee System, Waldemar Link GmbH & Co. KG (2021) Summary page 5.
- K151008: Link® Megasystem-C®, Waldemar Link GmbH & Co. KG (2015) Summary page 5.

## Indications for use
General Indications LINK Endo-Model EVO Knee System: The LINK Endo-Model EVO Knee System is intended for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures. This device is intended for cemented use only unless a cementless modular stem is indicated for use. Indications: All LINK Endo-Model EVO components: * Primary and secondary osteoarthritis. * Rheumatoid arthritis. * Revision after primary or revision total knee replacement. * Bone necroses which won't compromise the successful implantation of a hinged total knee endoprosthesis. * Varus and valgus deformity with contracture or laxity of the medial or lateral stabilizers. The LINK Endo-Model EVO Pure Hinge is additionally indicated for: * Extreme cases of varus/valgus deformities (20-300), rheumatoid arthritis, muscular deficiency and any kind of genu laxum. * Oncological and revision surgery in lower limb (in conjunction with the Endo-Model EVO -W and the Megasystem-C) The LINK Endo-Model EVO Rotating Hinge is additionally indicated for: * Oncological and revision surgery in lower limb (in conjunction with the Endo-Model EVO -W and the Megasystem-C) General Indications Link OptiStems: The Link OptiStems are for use with the following LINK knee femoral components, both intracondylar and distal femoral replacement versions: LINK Endo-Model SL, LINK Endo-Model EVO-M, and LINK Endo-Model EVO-W and are indicated for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures. The Link OptiStems cemented are intended for cemented use only. The Link OptiStems cementless are intended for cementless use only. Indications: * Revision arthroplasty due to juxta-articular bone defects. * Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture. * Bone deficiencies, e.g. due to tumors, as well as in large post-revision and posttrauma segmental bone defects. * Oncological and revision surgery in the area of the distal femur (in conjunction with Endo-Model SL Rotational and Hinge Knee Prostheses or LINK Endo-Model EVO - M - W).

Source page: https://510kreport.com/device/K220628
Methodology: https://510kreport.com/methodology