Cleared Traditional

Posterior Fusion Plate, HA Posterior Fusion Plate (K200066) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence.

K200066 · Spinal Simplicity, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
332d
Days
Class 2
Risk

K200066 is an FDA 510(k) clearance for the Posterior Fusion Plate, HA Posterior 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 December 10, 2020 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K200066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2020
Decision Date December 10, 2020
Days to Decision 332 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
210d slower than avg
Panel avg: 122d · This submission: 332d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01455805 Completed Interventional Industry-sponsored

Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis

Efficacy and Quality of Life Following Treatment of Lumbar Spinal Stenosis, Spondylolisthesis or Degenerative Disc Disease With the Minuteman Interspinous Interlaminar Fusion Implant Versus Surgical Decompression

48
Patients (actual)
4
Sites
Treatment
Purpose
Open label
Masking
Condition studied Lumbar Spinal Stenosis; Spondylolisthesis; Degenerative Disc Disease
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Ganesan Baranidharan, Dr
Sponsor Spinal Simplicity LLC (industry)
Started 2012-06-01 → Primary completion 2024-03-01
Primary outcome
Change from baseline of clinical efficacy up to 60 months post procedure
Secondary outcome
measures of quality of life
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - PEK Spinous Process Plate

All 19
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K200066.
Minuteman G5 MIS Fusion Plate
K211880 · Spinal Simplicity, LLC · Mar 2022
Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate
K212781 · Spinal Simplicity, LLC · Dec 2021
Inspan ScrewLES Fusion System
K213266 · Lespine Innovations, LLC · Dec 2021
CoFix System
K201704 · Paradigm Spine GmbH · Aug 2020
SP-LINK™ System
K182352 · Medical Designs, LLC · Nov 2018
AERIAL™ Interspinous Fixation
K180817 · Globus Medical, Inc. · May 2018