Cleared Special

FlareHawk Interbody Fusion System (K220453) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K220453 · Integrity Implants, Inc. · Orthopedic device
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Mar 2022
Decision
35d
Days
Class 2
Risk

K220453 is an FDA 510(k) clearance for the FlareHawk Interbody 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 Integrity Implants, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on March 24, 2022 after a review of 35 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Integrity Implants, Inc. devices

Submission Details

510(k) Number K220453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2022
Decision Date March 24, 2022
Days to Decision 35 days
Submission Type Special
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
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

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 464
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K220453.
Ti3Z Lumbar Interbody System
K212811 · Zavation Medical Products, LLC · Apr 2022
Anteralign Spinal System with Titan nanoLOCK Surface Technology
K214010 · Medtronic Sofamor Danek USA · Apr 2022
Toro-L Interbody Fusion System
K213355 · Integrity Implants, Inc. · Mar 2022
X-Pac Expandable Lumbar Cage System
K220655 · Expanding Innovations, Inc. · Mar 2022
PathLoc Lumbar Interbody Fusion Cage System
K213441 · L & K Biomed Co., Ltd. · Mar 2022
Genesys Spine 3DP Lumbar Interbody System
K220096 · Genesys Spine · Mar 2022