Cleared Traditional

K170224 - Spider Cervical Plating System

K170224 is the FDA 510(k) clearance for Spider Cervical Plating System by X-Spine Systems, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K170224 · X-Spine Systems, Inc. · Orthopedic device
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Jul 2017
Decision
162d
Days
Class 2
Risk

K170224 is an FDA 510(k) clearance for the Spider Cervical Plating System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by X-Spine Systems, Inc. (Miamisburg, US). The FDA issued a Cleared decision on July 6, 2017 after a review of 162 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 X-Spine Systems, Inc. devices

Submission Details

510(k) Number K170224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2017
Decision Date July 06, 2017
Days to Decision 162 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
40d slower than avg
Panel avg: 122d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 435
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K170224.
Ozark(tm) Cervical Plate System
K172104 · K2m, Inc. · Aug 2017
NOOSA Anterior Lumbar Plate System
K163625 · Signature Orthopaedics Pty, Ltd. · Aug 2017
EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System
K171439 · Medos International SARL · Jul 2017
Terrace™ Anterior Cervical Plate System
K163104 · Corelink, LLC · Jun 2017
Butrex Lumbar Buttress Plating System
K170530 · X-Spine Systems, Inc. · Mar 2017
LOSPA IS ACP System
K161641 · Corentec Co., Ltd. · Jan 2017