Cleared Traditional

K221399 - ZIP™ MIS Interspinous Fusion System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221399 · Aurora Spine, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2022
Decision
56d
Days
Class 2
Risk

K221399 is an FDA 510(k) clearance for the ZIP™ MIS Interspinous Fusion System. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Aurora Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 8, 2022 after a review of 56 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 Aurora Spine, Inc. devices

Submission Details

510(k) Number K221399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2022
Decision Date July 08, 2022
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Mcra, LLC
Justin Eggleton

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 47
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K221399.
Minuteman® G6 MIS Fusion Plate
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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