Cleared Traditional

K153436 - LATERAL Spine Truss System

K153436 is an FDA 510(k) clearance for LATERAL Spine Truss System, manufactured by 4Web, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K153436 · 4Web, Inc. · Orthopedic device
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Jun 2016
Decision
192d
Days
Class 2
Risk

K153436 is an FDA 510(k) clearance for the LATERAL Spine Truss 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 4Web, Inc. (Frisco, US). The FDA issued a Cleared decision on June 6, 2016 after a review of 192 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 4Web, Inc. devices

FDA 510(k) Submission Details - K153436

510(k) Number K153436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2015
Decision Date June 06, 2016
Days to Decision 192 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
70d slower than avg
Panel avg: 122d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

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

Silver Pine Consulting, LLC
Rich Jansen

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 896
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K153436.
Nanovis Intervertebral Body Fusion System and FortiCore®
K160874 · Nanovis, LLC · Jun 2016
CoRoent® Ti-C System
K160916 · Nu Vasive, Incorporated · Jun 2016
Lucent Intervertebral Body Fusion Device
K152011 · Spinal Elements, Inc. · Jun 2016
Reliance Lumbar IBF System
K160463 · Reliance Medical Systems, LLC · May 2016
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System
K153107 · Choicespine, LP · May 2016
NeoFuse HA Enhanced PLIF/TLIF
K153615 · Ht Medical, LLC · May 2016