# K050701: Thigh and Foot Positioner, Suprone Plus, Model RT-6010

- Pathway: 510(k) (Traditional)
- Applicant: Bionix Development Corp.
- Decided: Apr 1, 2005 after 14 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: 1 generation back to K933227 (1994). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933227: Uni-Frame Head Immobilization System, Medtec, Inc. (1994) Summary page 4.
- K021124: Accufix Tilting Radiotranslucent Headholder, Wfr/Aquaplast Corp. (2002) Summary page 6.
- (no number) Dual Leg Positioner: named in the summary without a submission number
- (no number) Knee-and-Foot Lok: named in the summary without a submission number
- (no number) Kneefix Cushion: named in the summary without a submission number
- (no number) Feetfix Cushion: named in the summary without a submission number

## Most influential descendants
- K122888: CDR Systems Precision Patient Positioning System (2013), 5 descendants of its own
- K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement (2016), 3 descendants of its own
- K210894: Siddharth-II; Impact (2021), 1 descendant of its own
- K222762: Siddharth-II;Impact (2023), 0 descendants of its own
- K182079: Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask (2018), 0 descendants of its own

## Indications for use
The Bionix Thigh and Foot Positioner 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/K050701
Methodology: https://510kreport.com/methodology