Cleared Traditional

K261284 - Invictus® Small Stature Spinal Fixation System

Also marketed or referenced as:
Invictus® 2.0 Spinal Fixation System

K261284 is an FDA 510(k) clearance for Invictus Small Stature Spinal Fixation ..., manufactured by Alphatec Spine, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K261284 · Alphatec Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
88d
Days
Class 2
Risk

K261284 is an FDA 510(k) clearance for the Invictus® Small Stature 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 July 14, 2026 after a review of 88 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

FDA 510(k) Submission Details - K261284

510(k) Number K261284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2026
Decision Date July 14, 2026
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

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 873
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K261284.
Tiger 2 System
K253943 · Zavation Medical Products, LLC · Jul 2026
QUATTRO Spinal system (Open Configuration)
K260362 · MANTIZ Co., Ltd. · Jul 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K253802 · S.M.A.I.O · Jul 2026
“Socko” Vimax Spinal Fixation System
K253045 · Socko Medical Co., Ltd. · Jun 2026
ChanPin Pedicle Screw Spinal System
K251251 · Chanpin Medtak Co., Ltd. · Jun 2026
Varion Thoracolumbar Fixation System
K260989 · Kyocera Medical Technologies Inc. (KMTI) · May 2026