Cleared Traditional

K232275 - Invictus Spinal Fixation System

K232275 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 58-day FDA review.

K232275 · Alphatec Spine, Inc. · Orthopedic device
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Sep 2023
Decision
58d
Days
Class 2
Risk

K232275 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 September 27, 2023 after a review of 58 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 K232275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2023
Decision Date September 27, 2023
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 651
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K232275.
VEOS Spinal Fixation System
K231658 · Spineway · Oct 2023
CarboClear® Pedicle Screw System
K232341 · CarboFix Orthopedics , Ltd. · Oct 2023
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K232650 · S.M.A.I.O · Sep 2023
TriALTIS Spine System
K231479 · Medos International SARL · Sep 2023
NIDO™ Pedicle Screw System
K230974 · Kalitec Medical · Sep 2023
Zenius™ Spinal System
K232218 · Medyssey USA, Inc. · Aug 2023