Cleared Traditional

X-PAC® LLIF Expandable Lateral Cage System (K251003) - FDA 510(k) Clearance

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

K251003 · Expanding Innovations, Inc. · Orthopedic device
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Jun 2025
Decision
85d
Days
Class 2
Risk

K251003 is an FDA 510(k) clearance for the X-PAC® LLIF Expandable Lateral Cage System. 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 Expanding Innovations, Inc. (Mountain View, US). The FDA issued a Cleared decision on June 25, 2025 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Expanding Innovations, Inc. devices

Submission Details

510(k) Number K251003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2025
Decision Date June 25, 2025
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 Consultant

Helix Medical, LLC
Carolyn Guthrie

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 464
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K251003.
TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
K251502 · Life Spine, Inc. · Jul 2025
aprevo® posterior/transforaminal lumbar interbody fusion device
K250987 · Carlsmed, Inc. · Jun 2025
Testa TP Pivoting Spacer System
K243816 · Spine Wave, Inc. · Jun 2025
X-PAC® TLIF Expandable Posterior Cage System
K251617 · Expanding Innovations, Inc. · Jun 2025
FIX-L PEEK PLIF and T-PLIF System
K243973 · Jeil Medical Corporation · Jun 2025
Tera Lumbar Interbody Fusion System (Various PNs)
K251335 · Acuity Surgical Devices, LLC · Jun 2025