Cleared Traditional

aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF) (K241328) - FDA 510(k) Clearance

Also marketed or referenced as:
aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF) aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)

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

K241328 · Carlsmed, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2024
Decision
94d
Days
Class 2
Risk

K241328 is an FDA 510(k) clearance for the aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF). 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 Carlsmed, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 12, 2024 after a review of 94 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 K241328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2024
Decision Date August 12, 2024
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
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 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 K241328.
COSINE™ Spacer
K234035 · Globus Medical, Inc. · Sep 2024
IB3D™ PL Spinal System
K241164 · Medicrea International S.A.S. (Medtronic) · Sep 2024
Adaptix™ PEEK Interbody System with Nanotechnology
K241605 · Nanovis, LLC · Sep 2024
Solar™ Lumbar Interbody Fusion System
K240326 · Degen Medical, Inc. · Jul 2024
sagAlign Lumbar Cage System (Various PNs)
K241413 · Acuity Surgical Devices, LLC · Jul 2024
SPIRA® Anterior Lumbar Spacers
K234077 · Camber Spine Technologies · Jul 2024