Cleared Traditional

aprevo® anterior lumbar interbody fusion device with interfixation (K222009) - FDA 510(k) Clearance

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

K222009 · Carlsmed, Inc. · Orthopedic device
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Nov 2022
Decision
138d
Days
Class 2
Risk

K222009 is an FDA 510(k) clearance for the aprevo® anterior lumbar interbody fusion device with interfixation. 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 November 22, 2022 after a review of 138 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 K222009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2022
Decision Date November 22, 2022
Days to Decision 138 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
16d slower than avg
Panel avg: 122d · This submission: 138d
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 K222009.
Pisces™-SA STANDALONE ALIF Interbody System
K223413 · Osseus Fusion Systems · Feb 2023
EVOLUTION SPINE Interbody System
K223146 · Evolution Spine · Feb 2023
EL CAPITAN Anterior Lumbar Interbody Fusion
K222554 · Astura Medical · Jan 2023
MectaLIF Anterior Extension
K221545 · Medacta International S.A. · Oct 2022
NuVasive Cohere ALIF System Intervertebral Body Fusion Device
K221751 · Nu Vasive, Incorporated · Oct 2022
Standalone ALIF Interbody Fusion System
K221936 · Eminent Spine · Oct 2022