Cleared Traditional

“Socko” Vimax Spinal Fixation System (K253045) - FDA 510(k) Clearance

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

K253045 · Socko Medical Co., Ltd. · Orthopedic device
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Jun 2026
Decision
268d
Days
Class 2
Risk

K253045 is an FDA 510(k) clearance for the “Socko” Vimax 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 Socko Medical Co., Ltd. (New Taipei, TW). The FDA issued a Cleared decision on June 17, 2026 after a review of 268 days - an extended review 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: 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 Socko Medical Co., Ltd. devices

Submission Details

510(k) Number K253045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2025
Decision Date June 17, 2026
Days to Decision 268 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 122d · This submission: 268d
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 448
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K253045.
Varion Thoracolumbar Fixation System
K260989 · Kyocera Medical Technologies Inc. (KMTI) · May 2026
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System
K253739 · Globus Medical, Inc. · May 2026
AccelFix Spinal Fixation System
K261130 · L & K Biomed Co., Ltd. · May 2026
PERLA® TL Posterior Thoraco-lumbar Fixation System
K253966 · Spineart SA · May 2026
LEO Spinal System
K252542 · ZheJiang Decans Medical Devices Co., Ltd. · Apr 2026
M.U.S.T. Pedicle Screw System - Extension
K253940 · Medacta International S.A. · Apr 2026