Cleared Traditional

K162995 - Ibis Pedicle Screw System

K162995 is an FDA 510(k) clearance for Ibis Pedicle Screw System, manufactured by Ortho Development Corporation. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K162995 · Ortho Development Corporation · Orthopedic device
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Mar 2017
Decision
154d
Days
Class 2
Risk

K162995 is an FDA 510(k) clearance for the Ibis® 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 Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on March 30, 2017 after a review of 154 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 Ortho Development Corporation devices

FDA 510(k) Submission Details - K162995

510(k) Number K162995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2016
Decision Date March 30, 2017
Days to Decision 154 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 122d · This submission: 154d
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 Peers - NKB Thoracolumbosacral Pedicle Screw System

All 707
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K162995.
Threshold™ V2 Pedicular Fixation System
K170255 · Spineology, Inc. · Apr 2017
Palisade™ Pedicular Fixation System
K170266 · Spineology, Inc. · Apr 2017
Fortress™ Pedicular Fixation System
K170268 · Spineology, Inc. · Apr 2017
USS System
K170654 · Synthes USA Products, LLC · Mar 2017
SeaSpine® Daytona® Small Stature Spinal System
K163604 · SeaSpine Orthopedics Corporation · Mar 2017
NuVasive® Reline® 4.5-5.0 System
K170126 · Nu Vasive, Incorporated · Mar 2017