Cleared Traditional

Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5

K221023 · Spinal Simplicity, LLC · Orthopedic

Aug 2022

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K221023 is an FDA 510(k) clearance for the Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5, 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 August 19, 2022, 135 days after receiving the submission on April 6, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K221023 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2022
Decision Date	August 19, 2022
Days to Decision	135 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.