# K143179: The LINK® Endo-Model® Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Jan 30, 2015 after 87 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945028 (1996). 2 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013385: Nexgen Complete Knee Solution Rotatng Hinge Knee, Zimmer, Inc. (2002) Summary page 5.

## Most influential descendants
- K152431: LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating (2016), 9 descendants of its own
- K202684: GMK Total Knee System - TiNbN Coating (2020), 3 descendants of its own
- K202924: LinkSymphoKnee System (2021), 2 descendants of its own
- K212742: GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating (2021), 1 descendant of its own
- K210010: GMK Revision & Hinge Extension - TiNbN Coating (2021), 1 descendant of its own

## Recalls of this device
- Jul 6, 2026 · Class II · Z-2934-2026: The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the platea
- 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
- Mar 18, 2021 · Class II · Z-2049-2023: The firm discovered through customer complaints that device segments may not meet specifications.
- Mar 18, 2021 · Class II · Z-2048-2023: The firm discovered through customer complaints that device segments may not meet specifications.
- Mar 18, 2021 · Class II · Z-2046-2023: The firm discovered through customer complaints that device segments may not meet specifications.
- Mar 18, 2021 · Class II · Z-2047-2023: The firm discovered through customer complaints that device segments may not meet specifications.

## 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/K143179
Methodology: https://510kreport.com/methodology