Cleared Traditional

K190398 - Republic Spine Restore Intervertebral Body Fusion System (FDA 510(k) Clearance)

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

K190398 · Republic Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
205d
Days
Class 2
Risk

K190398 is an FDA 510(k) clearance for the Republic Spine Restore Intervertebral Body Fusion System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Republic Spine, LLC (Boca Raton, US). The FDA issued a Cleared decision on September 12, 2019 after a review of 205 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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. 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 Republic Spine, LLC devices

Submission Details

510(k) Number K190398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2019
Decision Date September 12, 2019
Days to Decision 205 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 122d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 885
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K190398.
BEE PLIF Cage
K261067 · NGMedical GmbH · Apr 2026
SCRIPT™ Implant System
K253401 · Globus Medical, Inc. · Apr 2026
SWINGO-3D Lumbar Cage System
K254017 · Implanet · Feb 2026
LUX Expandable Lumbar Interbody System
K253583 · Xenix Medical · Feb 2026
Luna® Ti Interbody Fusion System
K250773 · Spinal Elements, Inc. · Feb 2026
Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System
K253748 · Life Spine, Inc. · Jan 2026