Cleared Traditional

K233793 - CarboClear X Pedicle Screw System

K233793 is the FDA 510(k) clearance for CarboClear X Pedicle Screw System by CarboFix Orthopedics , Ltd.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K233793 · CarboFix Orthopedics , Ltd. · Orthopedic device
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Aug 2024
Decision
247d
Days
Class 2
Risk

K233793 is an FDA 510(k) clearance for the CarboClear® X 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 CarboFix Orthopedics , Ltd. (Herzeliya, IL). The FDA issued a Cleared decision on August 1, 2024 after a review of 247 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.

View all CarboFix Orthopedics , Ltd. devices

Submission Details

510(k) Number K233793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2023
Decision Date August 01, 2024
Days to Decision 247 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
125d slower than avg
Panel avg: 122d · This submission: 247d
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 K233793.
Eminent Spine Scoliosis Deformity Pedicle Screw System
K242069 · Eminent Spine · Sep 2024
Orthopeasia Spinal Fixation System
K240180 · Orthopeasia Co., Ltd. · Aug 2024
Cortera™ Spinal Fixation System
K241892 · Xtant Medical Holdings, Inc. · Aug 2024
Pantheon Pedicle Screw and Iliac Bolt Fixation System
K241494 · Pantheon Spinal · Jul 2024
Erisma® Lp Spinal Fixation System
K241863 · Clariance · Jul 2024
Invictus® Small Stature Spinal Fixation System
K241519 · Alphatec Spine, Inc. · Jun 2024