Cleared Traditional

K190498 - Fortilink IBF System with TETRAfuse3D T...

K190498 is the FDA 510(k) clearance for Fortilink IBF System with TETRAfuse3D T... by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K190498 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
127d
Days
Class 2
Risk

K190498 is an FDA 510(k) clearance for the Fortilink® IBF System with TETRAfuse®3D Technology, include the following des.... 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 Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Alachua, US). The FDA issued a Cleared decision on July 5, 2019 after a review of 127 days - within the typical 510(k) review window.

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 Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) devices

Submission Details

510(k) Number K190498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2019
Decision Date July 05, 2019
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 Consultant

Musculoskeletal Clinical Regulatory Advisers, 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 595
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