# K152431: LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: May 9, 2016 after 257 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K936079 (1994). 24 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 34 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 4.
- K954186: Sled Unicompartment Knee System, Link America, Inc. (1996) Summary page 4.
- K122239: Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating 3DKNEE System with Tinbn Coating, Encore Medical L.P. (2013) Summary page 4.

## Most influential descendants
- 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
- K230471: LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface (2023), 0 descendants of its own

## Recalls of this device
- Mar 21, 2023 · Class II · Z-1544-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1549-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1552-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1543-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1551-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1550-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1541-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1554-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1540-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1553-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1548-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1545-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1539-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1547-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1542-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1546-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau

## Indications for use
The LINK® Endo-Model® and Sled Knee Systems with PorEx® (TiNbN) coating are 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. These devices are intended for cemented use only. The LINK® Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System with PorEx® (TiNbN) coating 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® Sled Knee System with PorEx® (TiNbN) coating is indicated for the following conditions: 1) Unicondylar arthrosis by intact ligaments including both cruciate ligaments 2) Valgus/Varus deformities <10°

Source page: https://510kreport.com/device/K152431
Methodology: https://510kreport.com/methodology