# K181465: SpaceOAR System

- Pathway: 510(k) (Special)
- Applicant: Augmenix, Inc.
- Decided: Jun 25, 2018 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: 1 generation back to DEN140030 (2015). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140030: SpaceOAR System, Augmenix, Inc. (2015) Summary page 4.

## Most influential descendants
- K182971: SpaceOAR Vue Hydrogel (2019), 2 descendants of its own
- K202224: SpaceOAR System (2020), 1 descendant of its own
- K262151: SpaceOAR Flex™ System (2026), 0 descendants of its own
- K260119: SpaceOAR Vue System (SV-2101) (2026), 0 descendants of its own
- 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 Hydrogel 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 Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Hydrogel 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/K181465
Methodology: https://510kreport.com/methodology