Cleared Traditional

K213460 - Invictus Spinal Fixation System

K213460 is the FDA 510(k) clearance for Invictus Spinal Fixation System by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K213460 · Alphatec Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
44d
Days
Class 2
Risk

K213460 is an FDA 510(k) clearance for the Invictus 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 Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 10, 2021 after a review of 44 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 Alphatec Spine, Inc. devices

Submission Details

510(k) Number K213460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2021
Decision Date December 10, 2021
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
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 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K213460.
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
Mariner Pedicle Screw System
K212692 · SeaSpine Orthopedics Corporation · Sep 2021
MOSS VRS Spinal System
K203607 · Biedermann Motech GmbH & Co. KG · Aug 2021
Golden Isles Pedicle Screw System
K212185 · Intelivation, LLC · Aug 2021