Cleared Traditional

K152259 - InFill Interbody Fusion Device

K152259 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 100-day FDA review.

K152259 · Pinnacle Spine Group, LLC · Orthopedic device
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Nov 2015
Decision
100d
Days
Class 2
Risk

K152259 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 November 19, 2015 after a review of 100 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 - K152259

510(k) Number K152259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2015
Decision Date November 19, 2015
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
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 K152259.
FORZA PTC Spacer System
K152475 · Orthofix, Inc. · Jan 2016
AccuLIF TL and PL Cage
K152651 · Stryker Corporation · Dec 2015
CONCORDE Bullet Lumbar Interbody System
K151773 · Medos International SARL · Nov 2015
Tritanium PL Cage
K152304 · Stryker · Nov 2015
PIVOX(tm) Oblique Lateral Spinal System
K152277 · Medtronic Sofamor Danek USA, Inc. · Nov 2015
Px HA PEEK IBF System
K151785 · Innovasis, Inc. · Oct 2015