# K253326: Oxiplex

- Pathway: 510(k) (Traditional)
- Applicant: Fziomed, Inc.
- Decided: May 1, 2026 after 213 days
- Product code: QVL (Absorbable Gel For Intraoperative Use In Spine Surgery)
- Device class: 2
- Regulation: 21 CFR 888.3047
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN240038 (2025). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN240038: Oxiplex®, Fziomed, Inc. (2025) Summary page 5.

## Indications for use
Oxiplex® is a synthetic, absorbable gel intended as an adjunct to lumbar spinal surgery in adult patients with leg pain, back pain, and neurological symptoms undergoing discectomy to reduce leg pain and neurological symptoms.

Source page: https://510kreport.com/device/K253326
Methodology: https://510kreport.com/methodology