Cleared Traditional

K150380 - ProMIS Fixation System

K150380 is an FDA 510(k) clearance for ProMIS Fixation System, manufactured by Premia Spine, Ltd.. 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.

K150380 · Premia Spine, Ltd. · Orthopedic device
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Jul 2015
Decision
154d
Days
Class 2
Risk

K150380 is an FDA 510(k) clearance for the ProMIS Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Premia Spine, Ltd. (Ramat Poleg, IL). The FDA issued a Cleared decision on July 17, 2015 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 Premia Spine, Ltd. devices

FDA 510(k) Submission Details - K150380

510(k) Number K150380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2015
Decision Date July 17, 2015
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 K150380.
Vitality Spinal Fixation System
K150896 · Zimmer Spine, Inc. · Aug 2015
Reform Pedicle Screw System
K151422 · Precision Spine, Inc. · Aug 2015
Everest Spinal System
K151216 · K2m, Inc. · Aug 2015
Nautilus Spinal System
K151196 · Life Spine, Inc. · Jul 2015
Reform Pedicle Screw System
K150856 · Precision Spine, Inc. · Jul 2015
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
K151488 · Orthofix, Inc. · Jul 2015