Cleared Traditional

K172826 - Cellent Spinal Systems

K172826 is the FDA 510(k) clearance for Cellent Spinal Systems by Jiangsu Trauhui Medical Instrument Co., Ltd.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 387-day FDA review.

K172826 · Jiangsu Trauhui Medical Instrument Co., Ltd. · Orthopedic device
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Oct 2018
Decision
387d
Days
Class 2
Risk

K172826 is an FDA 510(k) clearance for the Cellent Spinal Systems. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Jiangsu Trauhui Medical Instrument Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on October 10, 2018 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Jiangsu Trauhui Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K172826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2017
Decision Date October 10, 2018
Days to Decision 387 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
265d slower than avg
Panel avg: 122d · This submission: 387d
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 Consultant

Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
Mike Gu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K172826.
FUSE Pedicle Screw System
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PASS LP Spinal System
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Prase MIS Spinal System
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CarboClear® Pedicle Screw System
K182377 · CarboFix Orthopedics , Ltd. · Sep 2018
OsseoScrew System
K181980 · Alphatec Spine, Inc. · Sep 2018