Cleared Special

K151863 - Precision Spine Interspinous Plate System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K151863 · Precision Spine, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2015
Decision
30d
Days
Class 2
Risk

K151863 is an FDA 510(k) clearance for the Precision Spine Interspinous Plate System. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Precision Spine, Inc. (Parsippany, US). The FDA issued a Cleared decision on August 7, 2015 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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. Low regulatory complexity profile. 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

Submission Details

510(k) Number K151863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2015
Decision Date August 07, 2015
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PEK Spinous Process Plate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition A Posterior, Non-pedicle Supplemental Fixation Device Intended For Single Level Use In The Non-cervical Spine (t1-s1). It Is Intended For Single Level Plate Fixation/attachment To Spinous Process For The Purpose Of Achieving Supplemental Fusion In The Following Conditions: Degenerative Disc Disease (defined As Back Pain Of Discogenic Origin With Degeneration Of The Disc Confirmed By History And Radiographic Studies), Trauma (i.e., Fracture Or Dislocation), Spondylolisthesis, And/or Tumor. It Is Not Intended For Stand-alone Use.
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 - PEK Spinous Process Plate

All 47
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K151863.
Minuteman® G6 MIS Fusion Plate
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Minuteman G5 MIS Fusion Plate
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Minuteman G5 MIS Fusion Plate
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KeyLift™ Expandable Interlaminar Stabilization System
K232484 · Flospine · Oct 2023
primaLOK™ SP Interspinous Fusion System
K231807 · Wenzel Spine, Inc. · Aug 2023