Cleared Special

K153695 - Biomet Spine Fusion System

K153695 is an FDA 510(k) clearance for Biomet Spine Fusion System, manufactured by Biomet Spine, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 29-day FDA review.

K153695 · Biomet Spine, LLC · Orthopedic device
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Jan 2016
Decision
29d
Days
Class 2
Risk

K153695 is an FDA 510(k) clearance for the Biomet Spine Fusion 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 Biomet Spine, LLC (Broomfield, US). The FDA issued a Cleared decision on January 21, 2016 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet Spine, LLC devices

FDA 510(k) Submission Details - K153695

510(k) Number K153695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date January 21, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 661
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K153695.
PERIMETER Interbody Fusion Device
K160418 · Medtronic Sofamor Danek USA, Inc. · Mar 2016
Rampart A Lumbar Interbody Fusion Device
K153082 · Spineology, Inc. · Feb 2016
Half Dome Posterior Lumbar Interbody System
K152512 · Astura Medical · Jan 2016
AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer
K151726 · Stryker Corporation · Jan 2016
Spine Wave Gen II Expandable Interbody System
K152620 · Spine Wave, Inc. · Jan 2016
FORZA PTC Spacer System
K152475 · Orthofix, Inc. · Jan 2016