Cleared Traditional

aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation (K243802) - FDA 510(k) Clearance

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

K243802 · Carlsmed, Inc. · Orthopedic device
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Mar 2025
Decision
96d
Days
Class 2
Risk

K243802 is an FDA 510(k) clearance for the aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior.... Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Carlsmed, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 17, 2025 after a review of 96 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 K243802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2024
Decision Date March 17, 2025
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 111
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K243802.
Stable-L Lumbar Interbody System
K243934 · Nexus Spine, LLC · Apr 2025
Ventris Intervertebral Body Fusion Device
K243386 · Acuity Surgical Devices, LLC · Apr 2025
AxTiHA® Stand-Alone ALIF System
K250603 · Innovasis · Mar 2025
aprevo® anterior lumbar interbody fusion device with interfixation
K243635 · Carlsmed, Inc. · Dec 2024
Atlas Spine Lateral Expandable Interbody System
K243191 · Atlas Spine, Inc. · Nov 2024
DeGen Medical Patient Specific Implant (PSI) System
K241077 · Degen Medical · Oct 2024