Cleared Traditional

K262731 - Virata Spinal Fixation System

K262731 is an FDA 510(k) clearance for Virata Spinal Fixation System, manufactured by SeaSpine Orthopedics Corporation. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K262731 · SeaSpine Orthopedics Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
90d
Days
Class 2
Risk

K262731 is an FDA 510(k) clearance for the Virata Spinal Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on October 29, 2026 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 - K262731

510(k) Number K262731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2026
Decision Date October 29, 2026
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 914
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K262731.
AnyPlus II Spinal Fixation System
K261217 · GS Medical Co., Ltd. · Oct 2026
NOVIX Pedicle Screw System
K263062 · Tdm Co., Ltd. · Oct 2026
Duet™ Spinal Fixation System
K262712 · Duet Spine Holdings, LLC · Sep 2026
SAS MIS Pelvic Incidence Rods
K263172 · Spinal Alignment Solutions, Inc. · Sep 2026
Kentrospine Viktr-MIS® Pedicle screw system
K252139 · Rivarp Medical Pvt., Ltd. · Sep 2026
iFuse Granite Onyx™ Implant System
K262067 · SI-BONE, Inc. · Sep 2026
K262731 · Virata Spinal Fixation System
Download PDF FDA Summary SeaSpine Orthopedics …