Cleared Traditional

K171351 - Posterior Spine Truss System (PSTS) Int...

K171351 is an FDA 510(k) clearance for Posterior Spine Truss System (PSTS) Int..., 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 122-day FDA review.

K171351 · 4Web, Inc. · Orthopedic device
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Sep 2017
Decision
122d
Days
Class 2
Risk

K171351 is an FDA 510(k) clearance for the Posterior Spine Truss System (PSTS) Interbody Fusion Device. 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 September 8, 2017 after a review of 122 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 4Web, Inc. devices

FDA 510(k) Submission Details - K171351

510(k) Number K171351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date September 08, 2017
Days to Decision 122 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 122d · This submission: 122d
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 Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 644
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K171351.
NuVasive TLX Interbody System
K171633 · Nu Vasive, Incorporated · Sep 2017
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
K171107 · Medtronic Sofamor Danek USA, Inc. · Sep 2017
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
K172199 · Medtronic Sofamor Danek · Sep 2017
Duo Lumbar Interbody Fusion Device
K171660 · Spineology, Inc. · Aug 2017
ShurFit 2C Lumbar Interbody Fusion System
K171657 · Precision Spine, Inc. · Aug 2017
The TiBow Expandable Spacer System
K170919 · Life Spine, Inc. · Aug 2017