# K202224: SpaceOAR System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Aug 28, 2020 after 21 days
- Product code: OVB (Hydrogel Spacer)
- Device class: 2
- Regulation: 21 CFR 892.5725
- 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 DEN140030 (2015). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181465: SpaceOAR System, Augmenix, Inc. (2018) Summary page 4.

## Most influential descendants
- K220641: Barrigel Injectable Gel (2022), 0 descendants of its own

## Recalls of this device
- Feb 24, 2022 · Class II · Z-1002-2022: Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps 

## Indications for use
SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Source page: https://510kreport.com/device/K202224
Methodology: https://510kreport.com/methodology