Cleared Traditional

FaSet Fixation System (K222515) - FDA 510(k) Clearance

K222515 · Dio Medical Corporation · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2022
Decision
47d
Days
-
Risk

K222515 is an FDA 510(k) clearance for the FaSet Fixation System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Dio Medical Corporation (East Norriton, US). The FDA issued a Cleared decision on October 5, 2022 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. 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 Dio Medical Corporation devices

Submission Details

510(k) Number K222515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2022
Decision Date October 05, 2022
Days to Decision 47 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
75d faster than avg
Panel avg: 122d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 31
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K222515.
FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System
K232877 · K&J Consulting Corporation · Dec 2023
PMT Expandable Cage (PMT EXP)
K230297 · Providence Medical Technology, Inc. · Aug 2023
PMT Facet Fixation System (PMT FFS)
K220951 · Providence Medical Technology, Inc. · Dec 2022
Ion Facet Screw System
K211855 · SurGenTec, LLC · Feb 2022
CORRIDOR Fixation System
K192744 · Globus Medical, Inc. · Dec 2019
AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System
K192281 · Medos International SARL · Nov 2019