Cleared Traditional

Cortera™ Spinal Fixation System (K241892) - FDA 510(k) Clearance

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

K241892 · Xtant Medical Holdings, Inc. · Orthopedic device
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Aug 2024
Decision
35d
Days
Class 2
Risk

K241892 is an FDA 510(k) clearance for the Cortera™ 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 Xtant Medical Holdings, Inc. (Belgrade, US). The FDA issued a Cleared decision on August 2, 2024 after a review of 35 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 Xtant Medical Holdings, Inc. devices

Submission Details

510(k) Number K241892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2024
Decision Date August 02, 2024
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
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 K241892.
TriALTIS™ Spine System
K242042 · Medos International SARL · Sep 2024
Eminent Spine Scoliosis Deformity Pedicle Screw System
K242069 · Eminent Spine · Sep 2024
Orthopeasia Spinal Fixation System
K240180 · Orthopeasia Co., Ltd. · Aug 2024
CarboClear® X Pedicle Screw System
K233793 · CarboFix Orthopedics , Ltd. · Aug 2024
Pantheon Pedicle Screw and Iliac Bolt Fixation System
K241494 · Pantheon Spinal · Jul 2024
Erisma® Lp Spinal Fixation System
K241863 · Clariance · Jul 2024