Cleared Traditional

K251575 - IdentiTi™ II ALIF Standalone Interbody System (FDA 510(k) Clearance)

Also includes:
Transcend™ ALIF Standalone Interbody System

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

K251575 · Alphatec Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
104d
Days
Class 2
Risk

K251575 is an FDA 510(k) clearance for the IdentiTi™ II ALIF Standalone Interbody System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Alphatec Spine (Carlsbad, US). The FDA issued a Cleared decision on September 3, 2025 after a review of 104 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 Alphatec Spine devices

Submission Details

510(k) Number K251575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2025
Decision Date September 03, 2025
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 197
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K251575.
Ventana™ A Anterior Lumbar Interbody System
K253559 · Spinal Elements, Inc. · Feb 2026
DeGen Medical Patient Specific Implant (PSI) System
K251829 · Degen Medical · Dec 2025
CONDUIT™ SYNFIX™ Evolution Secured Spacer System
K250072 · Avalign Technologies, Inc. · Jul 2025
ProAM ALIF System
K251644 · Pro Surgical, Inc. · Jun 2025
Curiteva Porous PEEK Standalone ALIF System
K250845 · Curiteva, Inc. · Jun 2025
OneLIF™ Interbody Fusion System
K251459 · Novapproach Spine, LLC · Jun 2025