Cleared Traditional

MediRod Pedicle Screw System (K242764) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242764 · Cmf Medicon Surgical, Inc. · Orthopedic device
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Nov 2024
Decision
61d
Days
Class 2
Risk

K242764 is an FDA 510(k) clearance for the MediRod Pedicle Screw System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Cmf Medicon Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on November 13, 2024 after a review of 61 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 Cmf Medicon Surgical, Inc. devices

Submission Details

510(k) Number K242764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2024
Decision Date November 13, 2024
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
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 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K242764.
Reform Pedicle Screw System
K242297 · Precision Spine, Inc. · Dec 2024
LOCK-IN Spinal Fixation System
K243281 · Lock-In USA Corp · Dec 2024
4CIS® Chiron Spinal Fixation System
K231655 · Solco Biomedical Co., Ltd. · Nov 2024
Xpine Spinal Fixation System
K243004 · Jeil Medical Corporation · Nov 2024
CarboClear® Hybrid Pedicle Screw System
K243106 · CarboFix Orthopedics , Ltd. · Nov 2024
Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
K242350 · Spinal Alignment Solutions, Inc. · Oct 2024