Cleared Traditional

VyLink™ Spinal Screw System (K213750) - FDA 510(k) Clearance

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

K213750 · Vy Spine, LLC · Orthopedic device
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Feb 2022
Decision
90d
Days
Class 2
Risk

K213750 is an FDA 510(k) clearance for the VyLink™ Spinal Screw System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Vy Spine, LLC (Tallahassee, US). The FDA issued a Cleared decision on February 28, 2022 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.

View all Vy Spine, LLC devices

Submission Details

510(k) Number K213750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2021
Decision Date February 28, 2022
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.

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 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K213750.
Invictus® Spinal Fixation System
K214006 · Alphatec Spine, Inc. · Apr 2022
ARx® Spinal System
K220025 · Life Spine, Inc. · Mar 2022
EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)
K220374 · Medos International SARL · Mar 2022
True Tulip, True M.I.S.
K212627 · Innovative Surgical Designs, Inc. · Feb 2022
PERLA® TL Posterior Osteosynthesis System
K213470 · Spineart · Jan 2022
PASS LP™ Spinal System, CD Horizon™ Spinal System
K213281 · Medicrea International SA · Jan 2022