Cleared Traditional

K231809 - Momentum Posterior Spinal Fixation Syst...

Also marketed or referenced as:
Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement

K231809 is an FDA 510(k) clearance for Momentum Posterior Spinal Fixation Syst..., manufactured by Ulrich Medical USA. The device is a Class 2 Orthopedic device with product code PML cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K231809 · Ulrich Medical USA · Orthopedic device
Download Printable Device Report (PDF)
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Oct 2023
Decision
122d
Days
Class 2
Risk

K231809 is an FDA 510(k) clearance for the Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement. Classified as Bone Cement, Posterior Screw Augmentation (product code PML), Class II - Special Controls.

Submitted by Ulrich Medical USA (Plano, US). The FDA issued a Cleared decision on October 20, 2023 after a review of 122 days - within the typical 510(k) review window.

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 Ulrich Medical USA devices

FDA 510(k) Submission Details - K231809

510(k) Number K231809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2023
Decision Date October 20, 2023
Days to Decision 122 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 122d · This submission: 122d
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 16
Devices cleared under the same product code (PML) and FDA review panel - the closest regulatory comparables to K231809.
Dynamo™ Spinal Cement
K260286 · Spine Wave, Inc. · Jun 2026
OLYMPIC Posterior Spinal Fixation System
K252885 · Astura Medical · Jan 2026
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
K241034 · Medacta International S.A. · Jun 2024
PERLA® TL System
K230774 · Spineart · Jun 2023
VADER® Pedicle System, G21 Cement
K222789 · Icotec AG · Jan 2023
Invictus® Bone Cement, Invictus Spinal Fixation System
K221926 · Alphatec Spine, Inc. · Dec 2022