Cleared Special

K151215 - Mercury Spinal System

K151215 is an FDA 510(k) clearance for Mercury Spinal System, manufactured by Spinal Elements, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 28-day FDA review.

K151215 · Spinal Elements, Inc. · Orthopedic device
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Jun 2015
Decision
28d
Days
Class 2
Risk

K151215 is an FDA 510(k) clearance for the Mercury Spinal System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 3, 2015 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spinal Elements, Inc. devices

FDA 510(k) Submission Details - K151215

510(k) Number K151215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2015
Decision Date June 03, 2015
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

NKB Device Classification - Class 2, Special Controls

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 888
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K151215.
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
K142752 · Zimmer Spine, Inc. · Jun 2015
Dymaxeon Spine System
K150184 · Back 2 Basics Direct, LLC · Jun 2015
Iliad Pedicle Screw System and Zenius Pedicle Screw System
K142835 · Medyssey USA, Inc. · Jun 2015
APEX-DL Spine System
K143683 · Spinecraft, LLC · May 2015
Response 5.5/6.0 Spine System
K150600 · OrthoPediatrics Corp. · May 2015
ASTRA SPINE SYSTEM
K150417 · Spinecraft, LLC · May 2015