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
Download Printable Device Report (PDF)
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
Combination Product No
PCCP Authorized No
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 Consultant

Hogans Lovells US LLP
JANICE M. HOGAN

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 48
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