# K243057: TrueFit Bolus; TrueFlex Bolus

- Pathway: 510(k) (Special)
- Applicant: Adaptiiv Medical Technologies, Inc.
- Decided: Oct 23, 2024 after 26 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K971367 (1997). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213438: 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory, Adaptiiv (2022) Summary page 5.

## Most influential descendants
- K260308: TrueFit Bolus (2026), 0 descendants of its own

## Indications for use
TrueFit/TrueFlex Bolus is indicated for and intended to be placed on the patient’s skin as an accessory to attenuate and/or compensate the external beam (photon or electron) radiation during the treatment of various types of cancer. The device is for a single patient’s use only and can be reused throughout the entirety of the treatment course. The device is designed by the radiation therapy professional using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use. The device is restricted to sale by or on the order of a physician and is by prescription only.

Source page: https://510kreport.com/device/K243057
Methodology: https://510kreport.com/methodology