Cleared Traditional

K231743 - F3D Lateral Lumbar Interbody System

K231743 is the FDA 510(k) clearance for F3D Lateral Lumbar Interbody System by Corelink, LLC. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K231743 · Corelink, LLC · Orthopedic device
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Dec 2023
Decision
177d
Days
Class 2
Risk

K231743 is an FDA 510(k) clearance for the F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and.... 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 Corelink, LLC (St. Louis, US). The FDA issued a Cleared decision on December 8, 2023 after a review of 177 days - an extended review 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: 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 Corelink, LLC devices

Submission Details

510(k) Number K231743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2023
Decision Date December 08, 2023
Days to Decision 177 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
55d slower than avg
Panel avg: 122d · This submission: 177d
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

Empirical Technologies
Nathan Wright

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 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K231743.
Curiteva Porous PEEK Lumbar Interbody Fusion System
K233744 · Curiteva, Inc. · Jan 2024
Meridian Interbody System
K233694 · SeaSpine Orthopedics Corporation · Jan 2024
Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System
K230872 · Shanghai Sanyou Medical Co, Ltd. · Dec 2023
TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System
K232611 · Life Spine, Inc. · Nov 2023
Expandable Lumbar Fusion Cage (Type I,Type II)
K232069 · Shanghai Reach Medical Instrument Co, Ltd. · Nov 2023
Peridot-EX Expandable Intervertebral Body Fusion System
K232292 · Gbs Commonwealth Co., Ltd. · Nov 2023