Cleared Traditional

K172967 - Mercury Spinal System

K172967 is the FDA 510(k) clearance for Mercury Spinal System by Spinal Elements, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K172967 · Spinal Elements, Inc. · Orthopedic device
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Apr 2018
Decision
196d
Days
Class 2
Risk

K172967 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 April 10, 2018 after a review of 196 days - an extended review 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: 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 Spinal Elements, Inc. devices

Submission Details

510(k) Number K172967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2017
Decision Date April 10, 2018
Days to Decision 196 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
74d slower than avg
Panel avg: 122d · This submission: 196d
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 Peers - NKB Thoracolumbosacral Pedicle Screw System

All 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K172967.
SeaSpine Daytona Small Stature Spinal System
K180686 · SeaSpine Orthopedics Corporation · May 2018
ENNOVATE®
K180433 · Aesculap Implant Systems, LLC · Apr 2018
FOCUS Pedicle Screw System
K180458 · Nvision Biomedical Technologies, LLC · Apr 2018
AXIS 5.5 Lumbar Pedicle Screw System
K180301 · Axis Orthopaedics · Apr 2018
Patriot Spinal Fixation System
K180324 · Valorus Spine · Apr 2018
K2M Patient Specific Rods
K180376 · K2m, Inc. · Apr 2018