Cleared Traditional

K233951 - CD Horizon ModuLeX Spinal System (Shanks

K233951 is the FDA 510(k) clearance for CD Horizon ModuLeX Spinal System (Shanks by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K233951 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Mar 2024
Decision
103d
Days
Class 2
Risk

K233951 is an FDA 510(k) clearance for the CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw). Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on March 27, 2024 after a review of 103 days - within the typical 510(k) review window.

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: 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K233951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2023
Decision Date March 27, 2024
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
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 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K233951.
NewPort Spinal System
K232566 · SeaSpine Orthopedics Corporation · Apr 2024
G Surgical Marksman MIS System
K240737 · G Surgical, LLC · Apr 2024
AnyPlus II Spinal Fixation System
K240350 · GS Medical Co., Ltd. · Apr 2024
Vital™ Spinal Fixation System
K240539 · Zimvie Spine (Zimmer Biomet Spine, Inc.) · Mar 2024
4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
K232607 · Solco Biomedical Copany India Private Limited · Feb 2024
VADER® Pedicle System
K232628 · Icotec AG · Feb 2024