# K190386: KTA Adipose Treatment Kit

- Pathway: 510(k) (Traditional)
- Applicant: Stemics S.A.S
- Decided: Oct 10, 2019 after 233 days
- Product code: MUU (System, Suction, Lipoplasty)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K910696 (1991). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081848: Lipose Fat Transfer System, Lipose Corp. (2008) Summary page 4.
- K121005: Adiprep Adipose Transfer System, Harvest Technologies, Corp. (2012) Summary page 4.

## Indications for use
The KTA Adipose Treatment Kit is intended for medical and surgical procedures involving autologous fat grafting that consists in: -harvesting, -centrifuging, and -reinjecting autologous adipose tissue, Within the same procedure. The KTA Adipose Treatment Kit range consists in a family of products which are designed to harvest, process with minimal manipulation and reinject small – KTAMICRO, KTAEASY, KTAMY – to large –KTAMACRO, KTAMACROMED, KTASPIN – volumes of autologous fat in the following specialties: Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Arthroscopic Surgery.

Source page: https://510kreport.com/device/K190386
Methodology: https://510kreport.com/methodology