Cleared Traditional

K262343 - Dynavisc

K262343 is an FDA 510(k) clearance for Dynavisc, manufactured by Fziomed, Inc.. The device is a Class 2 Orthopedic device with product code OWW cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K262343 · Fziomed, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
110d
Days
Class 2
Risk

K262343 is an FDA 510(k) clearance for the Dynavisc. Classified as Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (product code OWW), Class II - Special Controls.

Submitted by Fziomed, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on October 28, 2026 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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.

FDA 510(k) Submission Details - K262343

510(k) Number K262343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2026
Decision Date October 28, 2026
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWW Device Classification - Class 2, Special Controls

Product Code OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures.
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 Peers - OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

All 10
Devices cleared under the same product code (OWW) and FDA review panel - the closest regulatory comparables to K262343.
VersaCoat Tendon Protector (VTP-44G2)
K251655 · Alafair Biosciences · Jul 2025
Rotium
K250021 · Nanofiber Solutions, LLC · Feb 2025
BioBrace®
K242187 · Conmed Corporation · Nov 2024
BioBrace® Reinforced Implant
K241906 · Conmed Corporation · Jul 2024
VersaWrap
K240817 · Alafair Biosciences, Inc. · Jun 2024
SpinMedix Absorbable Fibrous Membrane
K222220 · Celestray Biotech Company, LLC., · Jul 2023
K262343 · Dynavisc
Download PDF FDA Summary Fziomed, Inc.