# K100847: Synthetic Seeding Spacer Model SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles, Inc.
- Decided: May 21, 2010 after 57 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The WorldWide Medical Technologies Synthetic Seeding Spacers intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach for radionuclide seed application in and around the prostate. The devices are sterile, single patient use product.

Source page: https://510kreport.com/device/K100847
Methodology: https://510kreport.com/methodology