# K212742: GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating

- Pathway: 510(k) (Special)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Sep 16, 2021 after 17 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K936079 (1994). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182872: LINK GEMINI SL Total Knee System, Waldemar Link GmbH & Co. KG (2019) 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.

## Most influential descendants
- K220628: LINK Endo-Model EVO Knee System (2022), 0 descendants of its own

## Recalls of this device
- 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 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
- May 24, 2022 · Class II · Z-1380-2022: There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
- May 24, 2022 · Class II · Z-1377-2022: There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
- May 24, 2022 · Class II · Z-1378-2022: There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
- May 24, 2022 · Class II · Z-1379-2022: There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.

## Indications for use
The GEMINI SL Total Knee System is indicated for patients suffering from disability due to: 1) Degenerative, post-traumatic or rheumatoid arthritis; 2) Avascular necrosis of the femoral condyle; 3) Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; 4) Moderate valgus, varus or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts. The device is indicated for cemented use. Only cementless labeled modular stems are indicated for uncemented use. The Endo-Model and Sled Knee Systems with LINK 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 Endo-Model Rotating Hinge and Modular Rotating Hinge Knee System with LINK 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 Sled Knee System with LINK 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/K212742
Methodology: https://510kreport.com/methodology