Cleared Traditional

K261607 - Minuteman G6 MIS Fusion Plate

Also marketed or referenced as:
Minuteman G5 MIS Fusion Plate Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate) HA Minuteman G3-R MIS Fusion Plate Minuteman G3/HA Minuteman G3 Patriot SI Implant System Liberty SI Lateral Implant System

K261607 is an FDA 510(k) clearance for Minuteman G6 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 141-day FDA review.

K261607 · Spinal Simplicity, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
141d
Days
Class 2
Risk

K261607 is an FDA 510(k) clearance for the Minuteman G6 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 October 2, 2026 after a review of 141 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 Spinal Simplicity, LLC devices

FDA 510(k) Submission Details - K261607

510(k) Number K261607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2026
Decision Date October 02, 2026
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
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 48
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K261607.
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
Huvex Interspinous Fusion System
K223790 · Dio Medical Corp. · Mar 2023