# K020683: Isorod PD-103 Implant, Model Ati-PD-103

- Pathway: 510(k) (Traditional)
- Applicant: Ati Medical, Inc.
- Decided: Dec 17, 2002 after 288 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 K874787 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013660: Genetra, Radiomed Corporation (2001)
- K010283: Theraseed (R) Palladium-103 Implant; Model 200, Theragenics Corp. (2001) Summary page 1.
- K973328: Intersource, International Brachytherapy S.A. (1998) Summary page 1.

## Indications for use
The AT1 Medical, Inc. IsoRod Pd-103 Radionuclide Brachytherapy Source is intended for permanent interstitial implantation for the treatment of selected localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, neck, lung, intra-abdominal, pancreas, prostate, and wesectable tumors, or for residual disease after excision of primary or secondary tumors. IsoRod Pd-103 implants may be used concurrently with or following treatment with other interventions, such as external beam therapy or chemotherapy.

Source page: https://510kreport.com/device/K020683
Methodology: https://510kreport.com/methodology