Cleared Traditional

Minuteman? G6 MIS Fusion Plate

K253250 · Spinal Simplicity, LLC · Orthopedic

Dec 2025

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K253250 is an FDA 510(k) clearance for the Minuteman? G6 MIS Fusion Plate, a Spinous Process Plate (Class II — Special Controls, product code PEK), submitted by Spinal Simplicity, LLC (Overland Park, US). The FDA issued a Cleared decision on December 1, 2025, 63 days after receiving the submission on September 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K253250 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2025
Decision Date	December 01, 2025
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PEK — Spinous Process Plate
Device Class	Class II — 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.