# K043596: Theraload Custom Loaded Needles, Models 200 and 125.S06

- Pathway: 510(k) (Special)
- Applicant: Theragenics Corp.
- Decided: Jan 26, 2005 after 28 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: 4 generations back to K801748 (1980). 15 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010283: Theraseed (R) Palladium-103 Implant; Model 200, Theragenics Corp. (2001) Summary page 1.
- K021343: Isoseeds I-125, Bebig Isotopen-Und Medizintechnik GmbH (2002) Summary page 1.
- K040339: Brachytherapy Strand Device, Bebig Isotopen-Und Medizintechnik GmbH (2004) Summary page 1.
- (no number) TheraStrand: named in the summary without a submission number

## Most influential descendants
- K062384: Cesium-131 Strand, Strand Preload, Preload, S-Cartridge (2006), 7 descendants of its own
- K092136: Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 (2009), 4 descendants of its own
- K180515: GammaTile (2018), 3 descendants of its own
- K190296: GammaTile (2019), 2 descendants of its own
- K190839: GammaTile (2020), 1 descendant of its own

## Indications for use
TheraLoadTM is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and spacers custom loaded according to the treatment plan. The brachytherapy source is intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors may be recurrent or residual following external beam or excision of primary tumor and may be superficial, intrathoracic (head, neck, lung), or intra-abdominal (pancreas, prostate).

Source page: https://510kreport.com/device/K043596
Methodology: https://510kreport.com/methodology