Cleared Special

K151863 - Precision Spine Interspinous Plate System

K151863 is an FDA 510(k) clearance for Precision Spine Interspinous Plate System, manufactured by Precision Spine, Inc.. The device is a Class 2 Orthopedic device with product code PEK cleared through the Special 510(k) pathway after a 30-day FDA review.

K151863 · Precision Spine, Inc. · Orthopedic device
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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

FDA 510(k) Submission Details - K151863

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

PEK Device Classification - Class 2, Special Controls

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 Consultant

Empirical Testing Corp
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 - PEK Spinous Process Plate

All 34
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K151863.
Spinal Elements' Spinous Process Plate System
K160465 · Spinal Elements, Inc. · Jul 2016
Precision Spine Interspinous Plate System
K160568 · Precision Spine, Inc. · May 2016
Benefix Interspinous Fixation System
K143631 · U&I Corporation · Sep 2015
Reliance Interspinous Plate System
K142217 · Reliance Medical Systems, LLC · Apr 2015
Affix IIS Spinous Process Plate System
K143388 · Nu Vasive, Incorporated · Mar 2015
Interspinous Plate System
K142378 · Precision Spine, Inc. · Dec 2014