Cleared Traditional

K180156 - SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180156 · Globus Medical, Inc. · Orthopedic device
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Mar 2018
Decision
47d
Days
Class 2
Risk

K180156 is an FDA 510(k) clearance for the SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on March 7, 2018 after a review of 47 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. 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K180156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2018
Decision Date March 07, 2018
Days to Decision 47 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 122d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K180156.
Minuteman® G6 MIS Fusion Plate
K253250 · Spinal Simplicity, LLC · Dec 2025
Minuteman G5 MIS Fusion Plate
K234051 · Spinal Simplicity, LLC · Jan 2024
Minuteman G5 MIS Fusion Plate
K233527 · Spinal Simplicity, LLC · Nov 2023
KeyLift™ Expandable Interlaminar Stabilization System
K232484 · Flospine · Oct 2023
primaLOK™ SP Interspinous Fusion System
K231807 · Wenzel Spine, Inc. · Aug 2023