Cleared Traditional

K172349 - InFill Interbody Fusion Device

K172349 is an FDA 510(k) clearance for InFill Interbody Fusion Device, manufactured by Pinnacle Spine Group, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K172349 · Pinnacle Spine Group, LLC · Orthopedic device
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Dec 2017
Decision
133d
Days
Class 2
Risk

K172349 is an FDA 510(k) clearance for the InFill® 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 Pinnacle Spine Group, LLC (Dallas, US). The FDA issued a Cleared decision on December 14, 2017 after a review of 133 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 Pinnacle Spine Group, LLC devices

FDA 510(k) Submission Details - K172349

510(k) Number K172349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2017
Decision Date December 14, 2017
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
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 659
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K172349.
ProLift® Expandable System
K173182 · Life Spine, Inc. · Dec 2017
TAURUS PEEK Cage System
K170389 · Medyssey USA, Inc. · Dec 2017
Cascadia Interbody System
K172009 · K2m, Inc. · Dec 2017
Varian cage
K172756 · Medyssey USA, Inc. · Dec 2017
Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System
K173153 · Nu Vasive, Incorporated · Dec 2017
Velofix™ TLIF Cage
K172419 · U&I Corporation · Dec 2017