Cleared Traditional

ARTFX MEDICAL Cervical PEEK Cages (K240893) - FDA 510(k) Clearance

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

K240893 · Artfx Medical · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2024
Decision
88d
Days
Class 2
Risk

K240893 is an FDA 510(k) clearance for the ARTFX MEDICAL Cervical PEEK Cages. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Artfx Medical (Jacksonville, US). The FDA issued a Cleared decision on June 28, 2024 after a review of 88 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 Artfx Medical devices

Submission Details

510(k) Number K240893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2024
Decision Date June 28, 2024
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 182
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K240893.
ZSFab Cervical Interbody System
K242734 · Zsfab · Nov 2024
Gemini Cervical Fusion Cage System
K242195 · ZheJiang Decans Medical Devices Co., Ltd. · Nov 2024
PYXIS 3D Titanium Cervical Cage system
K241738 · GS Medical Co., Ltd. · Aug 2024
Spectrum Spine Cervical Cage System
K240838 · Spectrum Spine, Inc. · May 2024
uCerv Flux™-C 3D Porous Titanium Cervical Interbody
K241396 · Ulrich Medical USA, Inc. · May 2024
MATRIX HA PEEK Cervical IBF System
K232619 · Sapphire Medical Group · Mar 2024