Cleared Traditional

K232341 - CarboClear® Pedicle Screw System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence.

K232341 · CarboFix Orthopedics , Ltd. · Orthopedic device
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Oct 2023
Decision
67d
Days
Class 2
Risk

K232341 is an FDA 510(k) clearance for the CarboClear® 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 October 10, 2023 after a review of 67 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 CarboFix Orthopedics , Ltd. devices

Submission Details

510(k) Number K232341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2023
Decision Date October 10, 2023
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02626624 Completed Interventional Industry-sponsored

Safety and Efficacy of the CarboClear Pedicle Screw System

CarboClear Pedicle Screw System

57
Patients (actual)
8
Sites
Treatment
Purpose
Open label
Masking
Condition studied Degenerative Disc Disease; Spondylolisthesis, Grade 1
Study design Single group
Eligibility All sexes · 21 Years+
Sponsor CarboFix Orthopedics Ltd. (industry)
Started 2015-12-27 → Primary completion 2022-12-28
Primary outcome
Fusion: Evaluated Radiographically (by AP, Lateral and Flexion/Extension X-Rays) by Independent Radiographic Core Lab.
Secondary outcome
Subject's Overall Well-Being: Assessed by 12-Item Short Form Health Survey (SF-12) Patient Questionnaire
View full study on ClinicalTrials.gov

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 895
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K232341.
PERLA® TL Posterior Thoraco-lumbar Fixation System
K253966 · Spineart SA · May 2026
LEO Spinal System
K252542 · ZheJiang Decans Medical Devices Co., Ltd. · Apr 2026
M.U.S.T. Pedicle Screw System - Extension
K253940 · Medacta International S.A. · Apr 2026
CD Horizon™ ModuLeX™ Fenestrated Screw Set
K260216 · Medtronic Sofamor Danek USA, Inc. · Apr 2026
ARx® SAI Implant System
K254274 · Life Spine, Inc. · Apr 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K260786 · S.M.A.I.O · Apr 2026