Cleared Traditional

Impulse Interbody Fusion System (K201287) - FDA 510(k) Clearance

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

K201287 · Degen Medical · Orthopedic device
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Dec 2020
Decision
222d
Days
Class 2
Risk

K201287 is an FDA 510(k) clearance for the Impulse 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 Degen Medical (Florence, US). The FDA issued a Cleared decision on December 22, 2020 after a review of 222 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.

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Submission Details

510(k) Number K201287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2020
Decision Date December 22, 2020
Days to Decision 222 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
100d slower than avg
Panel avg: 122d · This submission: 222d
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

Secure BioMed Evaluations
Linda Braddon

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 450
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K201287.
CarboClear Lumbar Cage System
K203683 · Carbofix Orthpedics , Ltd. · Jan 2021
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone 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, Modulus ALIF System
K203201 · Nu Vasive, Incorporated · Jan 2021
SIRION Lateral Lumbar Interbody Fusion
K202495 · Astura Medical, LLC · Jan 2021
Lucent XP, Lucent XP Curved
K202298 · Spinal Elements, Inc. · Dec 2020
Australis Anterior Lumbar Cage System
K202820 · Prism Surgical Designs Pty, Ltd. · Dec 2020
WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System
K201755 · SeaSpine Orthopedics Corporation · Dec 2020