Cleared Traditional

K170108 - Xultan 5.5 Pedicle Screw System

K170108 is an FDA 510(k) clearance for Xultan 5.5 Pedicle Screw System, manufactured by Met One Technologies. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K170108 · Met One Technologies · Orthopedic device
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May 2017
Decision
110d
Days
Class 2
Risk

K170108 is an FDA 510(k) clearance for the Xultan 5.5 Pedicle Screw System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Met One Technologies (El Paso, US). The FDA issued a Cleared decision on May 2, 2017 after a review of 110 days - within the typical 510(k) review window.

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 Met One Technologies devices

FDA 510(k) Submission Details - K170108

510(k) Number K170108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2017
Decision Date May 02, 2017
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Empirical Testing Corp
Kenneth C. Maxwell II

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 874
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K170108.
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
K170679 · Medtronic Sofamor Danek · May 2017
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System
K171082 · Orthofix, Inc. · May 2017
VIPER PRIME™ Screws with Fenestrations
K170543 · Medos International SARL · May 2017
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
K170942 · Choicespine, LP · Apr 2017
Zenius Spinal System
K170964 · Medyssey USA, Inc. · Apr 2017
Threshold™ Pedicular Fixation System
K170251 · Spineology, Inc. · Apr 2017