Cleared Traditional

K250908 - Virata Spinal Fixation System

K250908 is the FDA 510(k) clearance for Virata Spinal Fixation System by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K250908 · SeaSpine Orthopedics Corporation · Orthopedic device
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Jun 2025
Decision
84d
Days
Class 2
Risk

K250908 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 June 18, 2025 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K250908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2025
Decision Date June 18, 2025
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K250908.
JAZZ Spinal System
K252437 · Implanet · Aug 2025
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K251804 · S.M.A.I.O · Jul 2025
Momentum® Posterior Spinal Fixation System
K251719 · Ulrich Medical USA, Inc. · Jul 2025
RIVA Posterior Fixation System
K251154 · Ht Medical D.B.A. Xenix Medical · Jun 2025
Annex® 2 Adjacent Level System
K251131 · Spine Wave, Inc. · Jun 2025
COLONNADE Posterior Screw Fixation System
K250582 · CG Bio Co., Ltd. · May 2025