# K141713: Smartgraft 200 System

- Pathway: 510(k) (Traditional)
- Applicant: Ingeneron, Inc.
- Decided: Oct 28, 2014 after 125 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)
- K100114: Fat Concentration System, Biomet, Inc. (2010) Summary page 4.
- K121005: Adiprep Adipose Transfer System, Harvest Technologies, Corp. (2012) Summary page 4.

## Indications for use
The SmartGraft™ 200 system is intended to be used in medical procedures involving the harvesting, centrifugation and transferring of autologous adipose tissue. The SmartGraft™ 200 system is used for concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested with a legally marketed lipoplasty system. The SmartGraft™ 200 system is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired. » Neurosurgery, * Gastrointestinal Surgery, * Urological Surgery, * Plastic and Reconstructive Surgery, * General Surgery, * Orthopedic Surgery, * Gynecological Surgery, * Thoracic Surgery, * Laparoscopic Surgery, and * Arthroscopic Surgery

Source page: https://510kreport.com/device/K141713
Methodology: https://510kreport.com/methodology