Cleared Traditional

aprevo® Cervical ACDF (K242260) - FDA 510(k) Clearance

Also marketed or referenced as:
aprevo® Cervical ACDF-X aprevo® Cervical ACDF-X NO CAM

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

K242260 · Carlsmed, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
107d
Days
Class 2
Risk

K242260 is an FDA 510(k) clearance for the aprevo® Cervical ACDF. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Carlsmed, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 15, 2024 after a review of 107 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 Carlsmed, Inc. devices

Submission Details

510(k) Number K242260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2024
Decision Date November 15, 2024
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 178
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K242260.
EVOL® ha – Hyper C Cervical Interbody Fusion System
K250605 · Cutting Edge Spine, LLC · Mar 2025
FIX-C 3D Ti ACIF System
K243915 · Jeil Medical Corporation · Feb 2025
Xenco Medical CancelleX Cervical Interbody System
K243673 · Xenco Medical, LLC · Jan 2025
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