# K191755: SPAR-K Instruments (for use with Gemini SL Total Knee System)

- Pathway: 510(k) (Special)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Jul 18, 2019 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K936079 (1994). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 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 4.

## 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 intended for cemented use. Only cementless labeled modular stems are indicated for uncemented use

Source page: https://510kreport.com/device/K191755
Methodology: https://510kreport.com/methodology