Cleared Traditional

K231694 - MASADA Modular Spinal Fixation System

K231694 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 160-day FDA review.

K231694 · Astura Medical · Orthopedic device
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Nov 2023
Decision
160d
Days
Class 2
Risk

K231694 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 November 16, 2023 after a review of 160 days - an extended review 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: 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.

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Submission Details

510(k) Number K231694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2023
Decision Date November 16, 2023
Days to Decision 160 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 slower than avg
Panel avg: 122d · This submission: 160d
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 K231694.
TriALTIS™ Spine System
K233684 · Medos International SARL · Dec 2023
Mini-OSTEO Pedicle Fixation System
K231443 · Osteomed Ind?stria E Com?rcio DE Implantes Ltda · Nov 2023
ProMIS Extension Rod System
K232719 · Premia Spine, Ltd. · Nov 2023
ANAX™ 5.5 Spinal System
K231737 · Innosys Co., Ltd. · Oct 2023
PressON Spinal Fixation System
K233234 · Nexus Spine, LLC · Oct 2023
PERLA® TL Posterior Thoraco-lumbar Fixation System
K231069 · Spineart SA · Oct 2023