# K100264: T-Form Extremity Immobilizer, Model RT-6060

- Pathway: 510(k) (Traditional)
- Applicant: Bionix Development Corp.
- Decided: Apr 9, 2010 after 71 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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: 3 generations back to K905007 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060737: Sinmed Positioning Devices, Sinmed BV (2006) Summary page 1.
- K950866: Hip Fixation System, Medtec, Inc. (1995)

## Indications for use
The Bionix T-Form Extremities Immobilizer patient positioning system, developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

Source page: https://510kreport.com/device/K100264
Methodology: https://510kreport.com/methodology