Cleared Traditional

K221926 - Invictus® Bone Cement, Invictus Spinal Fixation System

K221926 is an FDA 510(k) clearance for Invictus Bone Cement, manufactured by Alphatec Spine, Inc.. The device is a Class 2 Orthopedic device with product code PML cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K221926 · Alphatec Spine, Inc. · Orthopedic device
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Dec 2022
Decision
172d
Days
Class 2
Risk

K221926 is an FDA 510(k) clearance for the Invictus® Bone Cement, Invictus Spinal Fixation System. Classified as Bone Cement, Posterior Screw Augmentation (product code PML), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 20, 2022 after a review of 172 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 Alphatec Spine, Inc. devices

FDA 510(k) Submission Details - K221926

510(k) Number K221926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2022
Decision Date December 20, 2022
Days to Decision 172 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
50d slower than avg
Panel avg: 122d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PML Device Classification - Class 2, Special Controls

Product Code PML Bone Cement, Posterior Screw Augmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
Definition The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.
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 - PML Bone Cement, Posterior Screw Augmentation

All 18
Devices cleared under the same product code (PML) and FDA review panel - the closest regulatory comparables to K221926.
Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
K231809 · Ulrich Medical USA · Oct 2023
PERLA® TL System
K230774 · Spineart · Jun 2023
VADER® Pedicle System, G21 Cement
K222789 · Icotec AG · Jan 2023
BonOs® Inject Bone Cement
K222256 · Neo Medical SA · Aug 2022
BonOs Inject Bone Cement
K212489 · Neo Medical SA · Oct 2021
G21 Cement, VADER® Pedicle System
K200596 · Icotec AG · Oct 2020