# K024183: Alton PT Stepper

- Pathway: 510(k) (Traditional)
- Applicant: Alton Design, LLC
- Decided: Mar 17, 2003 after 88 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- 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 K802032 (1980). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972152: Devmed Stepping and Stabilizing System, Devmed Corp. (1997) Summary page 1.
- K011581: Ameritek Brachytherapy Template, Amertek Medical, Inc. (2001) Summary page 1.
- K864807: Teknar Proscan (TM), Teknar, Inc. (1987) Summary page 1.
- K871413: Civco Stepper, CIVCO Medical Instruments Co., Inc. (1987) Summary page 1.
- K913293: Quick Seeder, Mick Radio-Nuclear Instruments, Inc. (1992) Summary page 1.
- K963302: Tayman Medical, Inc. Stepping & Stabilizing System, Tayman Medical, Inc. (1997) Summary page 1.
- K972672: Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support and Manual Adjustment Accessory, Barzell-Whitmore Maroon Bells, Inc. (1997) Summary page 1.
- K000960: Barzell-Whitmore Maroon Bells, Inc. Colo-Rectal Mover, Model 3900, Barzell-Whitmore Maroon Bells, Inc. (2000)
- K802032: Mini Mick Applicator, Mick Radio-Nuclear Instruments, Inc. (1980) Summary page 1.

## Indications for use
The Alton PT Stabilizer and Stepper is designed to allow precision ullrasound probe alignment, precise prostate visualization and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate for other) cancer. It is also used to allow precision ultrasound alignment and precise prostate visualization in cryotherapy treatments for prostate treatment.

Source page: https://510kreport.com/device/K024183
Methodology: https://510kreport.com/methodology