# K982696: Interplant

- Pathway: 510(k) (Traditional)
- Applicant: Burdette Medical Systems, Inc.
- Decided: Apr 1, 1999 after 241 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K850571 (1985). 7 ancestors in all.
1 later device descends 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)
- K924240: Prowess 2000, Small Systems Group, Inc. (1993) Summary page 1.
- K875241: Civco Seed Implant Needle Guide, CIVCO Medical Instruments Co., Inc. (1988) 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.
- (no number) Multimedia Medical Systems, Inc. B3DTUA TherapacPLUS dose planning: named in the summary without a submission number
- (no number) B&K Medical Systems HP-100 stepper/stand: named in the summary without a submission number
- (no number) COTAN stand/stabilizer: named in the summary without a submission number
- (no number) Northwest stand/stabilizer: named in the summary without a submission number

## Most influential descendants
- K131428: Radvision (2013), 0 descendants of its own

## Recalls of this device
- Dec 1, 2008 · Not classified · Z-2622-2011: Interplant Software: If the trajectory needle with a non-zero retraction is adjusted in any of the planning views (Transverse, 3D) and the program is closed and reopened, the Needle Definitions page i

## Indications for use
The Burdette Medical Systems, Inc. Interplant™ system is used in planning and performing a prostate brachytherapy implant procedure to provide ultrasound probe alignment and radioactive seed implantation. The Interplant™ device will use standard 125-Todine (*** I) or 103-Paladium (‘*’ Pd) isotope permanent implant radiation seeds for the treatment of prostate cancer. The system will allow volume measurement and dose calculation, relevant prostate anatomy and dose visualization, and post-treatment seed localization.

Source page: https://510kreport.com/device/K982696
Methodology: https://510kreport.com/methodology