# K182872: LINK GEMINI SL Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Apr 3, 2019 after 173 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K936079 (1994). 20 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923277: Foundation Knee System, Encore Orthopedics, Inc. (1993) Summary page 4.
- K933539: Foundation Posterior Stabilized Knee, Encore Orthopedics, Inc. (1994) 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
- K202924: LinkSymphoKnee System (2021), 2 descendants of its own
- K200912: Freedom (R) - TiNbN Coated Knee (2020), 2 descendants of its own
- K212839: Opulent TiNbN Coated Knee (2021), 1 descendant 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
- K230471: LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface (2023), 0 descendants of its own

## Indications for use
The LINK® GEMINI® SL® Total Knee System is indicated for patients suffering from disability due to: - Degenerative, post-traumatic or rheumatoid arthritis; - Avascular necrosis of the femoral condyle: - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; - 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.

Source page: https://510kreport.com/device/K182872
Methodology: https://510kreport.com/methodology