Cleared Traditional

K243259 - MASADA Modular Spinal Fixation System

K243259 is the FDA 510(k) clearance for MASADA Modular Spinal Fixation System by Astura Medical. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K243259 · Astura Medical · Orthopedic device
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Jan 2025
Decision
84d
Days
Class 2
Risk

K243259 is an FDA 510(k) clearance for the MASADA Modular 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 Astura Medical (Irving, US). The FDA issued a Cleared decision on January 7, 2025 after a review of 84 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 Astura Medical devices

Submission Details

510(k) Number K243259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2024
Decision Date January 07, 2025
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 K243259.
Tiger 2 System
K243908 · Zavation Medical Products, LLC · Feb 2025
TriALTIS™ Spine System
K243249 · Medos International SARL · Jan 2025
EffortMed Spinal Fixation System
K243946 · Effortmed, LLC · Jan 2025
NEO Pedicle Screw System™
K243693 · Neo Medical SA · Dec 2024
Reform Pedicle Screw System
K242297 · Precision Spine, Inc. · Dec 2024
LOCK-IN Spinal Fixation System
K243281 · Lock-In USA Corp · Dec 2024