Cleared Traditional

Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology (K172343) - FDA 510(k) Clearance

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

K172343 · Rti Surgical, Inc. · Orthopedic device
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Oct 2017
Decision
82d
Days
Class 2
Risk

K172343 is an FDA 510(k) clearance for the Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology. 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 Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on October 23, 2017 after a review of 82 days - a notably fast clearance 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: 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 Rti Surgical, Inc. devices

Submission Details

510(k) Number K172343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2017
Decision Date October 23, 2017
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
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 451
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K172343.
Cascadia Interbody System
K172009 · K2m, Inc. · Dec 2017
Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System
K173153 · Nu Vasive, Incorporated · Dec 2017
NuVasive® Modulus TLIF Interbody System
K172341 · Nu Vasive, Incorporated · Oct 2017
NuVasive® Modulus XLIF Interbody System
K172123 · Nu Vasive, Incorporated · Oct 2017
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
K171689 · Medtronic Sofamor Danek USA, Inc. · Oct 2017
NuVasive TLX Interbody System
K171633 · Nu Vasive, Incorporated · Sep 2017