Cleared Traditional

K151422 - Reform Pedicle Screw System

K151422 is an FDA 510(k) clearance for Reform Pedicle Screw System, manufactured by Precision Spine, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K151422 · Precision Spine, Inc. · Orthopedic device
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Aug 2015
Decision
85d
Days
Class 2
Risk

K151422 is an FDA 510(k) clearance for the Reform 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 Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on August 21, 2015 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Precision Spine, Inc. devices

FDA 510(k) Submission Details - K151422

510(k) Number K151422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2015
Decision Date August 21, 2015
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 706
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K151422.
Everest Spinal System
K151727 · K2m, Inc. · Sep 2015
Fortress Pedicular Fixation System
K152148 · Spineology, Inc. · Sep 2015
Vitality Spinal Fixation System
K150896 · Zimmer 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