Cleared Traditional

K142378 - Interspinous Plate System

K142378 is an FDA 510(k) clearance for Interspinous Plate System, manufactured by Precision Spine, Inc.. The device is a Class 2 Orthopedic device with product code PEK cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K142378 · Precision Spine, Inc. · Orthopedic device
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Dec 2014
Decision
114d
Days
Class 2
Risk

K142378 is an FDA 510(k) clearance for the 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 December 18, 2014 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Precision Spine, Inc. devices

FDA 510(k) Submission Details - K142378

510(k) Number K142378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2014
Decision Date December 18, 2014
Days to Decision 114 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
8d faster than avg
Panel avg: 122d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Corporation
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 K142378.
Precision Spine Interspinous Plate System
K151863 · Precision Spine, Inc. · Aug 2015
Reliance Interspinous Plate System
K142217 · Reliance Medical Systems, LLC · Apr 2015
Affix IIS Spinous Process Plate System
K143388 · Nu Vasive, Incorporated · Mar 2015
AILERON INTERSPINOUS FIXATION SYSTEM
K140236 · Life Spine, Inc. · Oct 2014
VIA SPINOUS PROCESS FIXATION SYSTEM
K142213 · Spineology, Inc. · Sep 2014
ROMEO 2 PAD POSTERIOR AXIAL DEVICE
K141508 · Spineart · Aug 2014