# DEN140030: SpaceOAR System

- Pathway: De Novo (Direct)
- Applicant: Augmenix, Inc.
- Decided: Apr 1, 2015 after 182 days
- Product code: OVB (Hydrogel Spacer)
- Device class: 2
- Regulation: 21 CFR 892.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K181465: SpaceOAR System (2018), 5 descendants of its own
- 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

## 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/DEN140030
Methodology: https://510kreport.com/methodology