Cleared Traditional

K253326 - Oxiplex (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253326 · Fziomed, Inc. · Orthopedic device
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May 2026
Decision
213d
Days
Class 2
Risk

K253326 is an FDA 510(k) clearance for the Oxiplex. Classified as Absorbable Gel For Intraoperative Use In Spine Surgery (product code QVL), Class II - Special Controls.

Submitted by Fziomed, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on May 1, 2026 after a review of 213 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3047 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Fziomed, Inc. devices

Submission Details

510(k) Number K253326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date May 01, 2026
Days to Decision 213 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 122d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QVL Absorbable Gel For Intraoperative Use In Spine Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3047
Definition This Device Is An Absorbable Gel Implant For Intraoperative Use In Spinal Procedures That Is Applied To Nerve Roots After Hemostasis Has Been Achieved And Prior To Closure. The Device Is Intended As An Adjunct To The Surgical Procedure To Reduce Pain And Neurological Symptoms.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

DuVal & Associates, P.A.
Lisa Pritchard

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.