Cleared Special

K150856 - Reform Pedicle Screw System

K150856 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 Special 510(k) pathway after a 98-day FDA review.

K150856 · Precision Spine, Inc. · Orthopedic device
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Jul 2015
Decision
98d
Days
Class 2
Risk

K150856 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 July 7, 2015 after a review of 98 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Precision Spine, Inc. devices

FDA 510(k) Submission Details - K150856

510(k) Number K150856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2015
Decision Date July 07, 2015
Days to Decision 98 days
Submission Type Special
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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

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 Consulting, LLC
Kenneth C Maxwell

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 706
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K150856.
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
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
K151488 · Orthofix, Inc. · Jul 2015
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
K142752 · Zimmer Spine, Inc. · Jun 2015
Mercury Spinal System
K151215 · Spinal Elements, Inc. · Jun 2015