# K021311: Synthetic Absorbable Seeding Spacers Made of Polydioxanone Material

- Pathway: 510(k) (Traditional)
- Applicant: Cp Medical
- Decided: Jul 13, 2002 after 79 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: 2 generations back to K010621 (2001). 2 ancestors in all.
6 later devices descend 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)
- K010621: Accu-Space Absorbable Seeding Spacers, Cp Medical (2001)
- K013964: Modification to Accu-Space Plain Gut Absorbable Seeding Spacers, Cp Medical (2002) Summary page 1.

## Most influential descendants
- K034062: CP Sleeve and River Sleeve (2004), 5 descendants of its own
- K103449: Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers (2011), 3 descendants of its own
- K131689: Mri Marker (2013), 1 descendant of its own
- K171487: Sirius MRI Marker NS (2017), 0 descendants of its own
- K120859: Pre-Loaded Gold Visicoil CK Marker (2012), 0 descendants of its own

## Indications for use
CP Medical's synthetic absorbable seeding spacers made of polydioxanone material are indicated for use in brachytherapy, soft tissues, or organ tissue but should not be used during cardiovascular or neurological procedures.

Source page: https://510kreport.com/device/K021311
Methodology: https://510kreport.com/methodology