Cleared Traditional

K141222 - NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM

K141222 is an FDA 510(k) clearance for NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT..., manufactured by Life Spine, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K141222 · Life Spine, Inc. · Orthopedic device
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Feb 2015
Decision
276d
Days
Class 2
Risk

K141222 is an FDA 510(k) clearance for the NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Life Spine, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on February 12, 2015 after a review of 276 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 Life Spine, Inc. devices

FDA 510(k) Submission Details - K141222

510(k) Number K141222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2014
Decision Date February 12, 2015
Days to Decision 276 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
154d slower than avg
Panel avg: 122d · This submission: 276d
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 887
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K141222.
Spinal System
K142576 · Eisertech, LLC · Feb 2015
Palladian Lumbar Pedicle Screw System
K143230 · Neurostructures, Inc. · Feb 2015
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
K143375 · Medtronic Sofamor Danek USA, Inc. · Feb 2015
CD HORIZON Spinal System
K143569 · Medtronic Sofamor Danek USA, Inc. · Feb 2015
CD HORIZON SPINAL SYSTEM
K150178 · Medtronic Sofamor Danek USA, Inc. · Feb 2015
STERISPINE PS Pedicle Screw
K150092 · Safe Orthopaedics · Feb 2015