Cleared Traditional

K151741 - HA Minuteman G3 MIS Fusion Plate

K151741 is an FDA 510(k) clearance for HA Minuteman G3 MIS Fusion Plate, manufactured by Spinal Simplicity, LLC. The device is a Class 2 Orthopedic device with product code PEK cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K151741 · Spinal Simplicity, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2015
Decision
55d
Days
Class 2
Risk

K151741 is an FDA 510(k) clearance for the HA Minuteman G3 MIS Fusion Plate. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Spinal Simplicity, LLC (Overland Park, US). The FDA issued a Cleared decision on August 20, 2015 after a review of 55 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 Spinal Simplicity, LLC devices

FDA 510(k) Submission Details - K151741

510(k) Number K151741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2015
Decision Date August 20, 2015
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 Peers - PEK Spinous Process Plate

All 35
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K151741.
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
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