Cleared Traditional

K201029 - Sapphire Spinal System

K201029 is the FDA 510(k) clearance for Sapphire Spinal System by Spinal Elements, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K201029 · Spinal Elements, Inc. · Orthopedic device
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Jun 2020
Decision
58d
Days
Class 2
Risk

K201029 is an FDA 510(k) clearance for the Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 17, 2020 after a review of 58 days - a notably fast clearance 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: 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 Spinal Elements, Inc. devices

Submission Details

510(k) Number K201029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2020
Decision Date June 17, 2020
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 K201029.
Aurora® Anterior Lumbar Plate Sytstem
K201079 · Prism Surgical Design Pty , Ltd. · Aug 2020
AccelFix Lumbar Plate System
K192481 · L & K Biomed Co., Ltd. · Jul 2020
Transept Cervical Plate System
K200927 · Neurostructures, Inc. · Jul 2020
CarboClear® Cervical Plate System
K200883 · CarboFix Orthopedics , Ltd. · Jun 2020
Meridian Anterior Plate System, Regatta Lateral Plate System
K200885 · SeaSpine Orthopedics Corporation · May 2020
NuVasive Thoracolumbar Plates
K200956 · Nu Vasive, Incorporated · May 2020