Cleared Traditional

ProAM ALIF System (K240126) - FDA 510(k) Clearance

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

K240126 · Pro Surgical, Inc. · Orthopedic device
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May 2024
Decision
108d
Days
Class 2
Risk

K240126 is an FDA 510(k) clearance for the ProAM ALIF System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Pro Surgical, Inc. (Encinitas, US). The FDA issued a Cleared decision on May 3, 2024 after a review of 108 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 Pro Surgical, Inc. devices

Submission Details

510(k) Number K240126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2024
Decision Date May 03, 2024
Days to Decision 108 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
14d faster than avg
Panel avg: 122d · This submission: 108d
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 K240126.
Interwedge® Standalone Lateral
K241487 · Foundation Surgical Group, Inc. · Oct 2024
Juliet® Ti LL Lumbar Interbody Device
K241321 · Spineart SA · Jul 2024
E3D™-A Interbody System
K240368 · Evolution Spine · May 2024
Omnia Medical TiBrid™-SA System
K240623 · Omnia Medical, LLC · Apr 2024
Anterior Spine Truss System-Stand Alone (ASTS-SA)
K233966 · 4Web Medical, Inc. · Apr 2024
E3D™-A Interbody System
K232432 · Evolution Spine · Jan 2024