Cleared Traditional

K201453 - Fortilink Cages with TiPlus Technology

K201453 is the FDA 510(k) clearance for Fortilink Cages with TiPlus Technology by Paradigm Spine GmbH. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K201453 · Paradigm Spine GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
128d
Days
Class 2
Risk

K201453 is an FDA 510(k) clearance for the Fortilink Cages with TiPlus 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 Paradigm Spine GmbH (New York, US). The FDA issued a Cleared decision on October 7, 2020 after a review of 128 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 Paradigm Spine GmbH devices

Submission Details

510(k) Number K201453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2020
Decision Date October 07, 2020
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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

Mcra, 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
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K201453.
Zavation IBF System
K200084 · Zavation Medical Products, LLC · Oct 2020
Zavation IBF System
K202305 · Zavation Medical Products, LLC · Oct 2020
GAIA Lumbar Interbody Fusion Device (LIFD) Family
K201939 · Printerprezz · Oct 2020
NuVasive® Cohere® Thoracolumbar Interbody System
K200953 · Nu Vasive, Incorporated · Oct 2020
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System
K201820 · Nu Vasive, Incorporated · Sep 2020
FlareHawk TiHawk9 Interbody Fusion System
K201367 · Integrity Implants, Inc. · Sep 2020