# K211768: LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE

- Pathway: 510(k) (Special)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Jun 30, 2021 after 22 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: 6 generations back to K936079 (1994). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 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.
- K151008: Link® Megasystem-C®, Waldemar Link GmbH & Co. KG (2015) Summary page 5.
- K821476: Bard Endo Link Intracondylar Rotating, C.R. Bard, Inc. (1982) 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 6.

## Indications for use
The LINK Endo-Model Knee System is indicated for patients with severe joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis. Joint fractures which disallow an osteosynthetic reconstruction. This device is intended for cemented use only unless a cementless modular stem is indicated for use. The LINK Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System are indicated for the following conditions: 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°. The LINK Endo-Model Non-Rotating Hinge and Modular Non-Rotating Hinge Knee System are indicated for the following conditions: 1) Bone necroses. 2) Bicondylar arthrosis by completely damaged ligaments and muscular instability. 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°. 10) Valgus/Varus deformities 20-30°.

Source page: https://510kreport.com/device/K211768
Methodology: https://510kreport.com/methodology