# K262151: SpaceOAR Flex™ System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Sep 11, 2026 after 78 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
Longest line of descent: 3 generations back to DEN140030 (2015). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182971: SpaceOAR Vue Hydrogel, Augmenix, Inc. (2019) Summary page 5.

## Indications for use
SpaceOAR Flex 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 Flex System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Flex System is composed of a radiopaque, biodegradable material that 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/K262151
Methodology: https://510kreport.com/methodology