Cleared Traditional

K211855 - Ion Facet Screw System

K211855 · SurGenTec, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
254d
Days
-
Risk

K211855 is an FDA 510(k) clearance for the Ion Facet Screw System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on February 25, 2022 after a review of 254 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 SurGenTec, LLC devices

Submission Details

510(k) Number K211855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2021
Decision Date February 25, 2022
Days to Decision 254 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
132d slower than avg
Panel avg: 122d · This submission: 254d
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 46
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K211855.
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
FaSet Fixation System
K222515 · Dio Medical Corporation · Oct 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
PMT Facet Screw
K183589 · Providence Medical Technology, Inc. · Oct 2019