Cleared Special

K112986 - LATERAL FUSION DEVICE

K112986 is an FDA 510(k) clearance for LATERAL FUSION DEVICE, manufactured by Integra Spine (Integra Lifesciences). The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 208-day FDA review.

K112986 · Integra Spine (Integra Lifesciences) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
208d
Days
Class 2
Risk

K112986 is an FDA 510(k) clearance for the LATERAL 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 Integra Spine (Integra Lifesciences) (Medina, US). The FDA issued a Cleared decision on May 1, 2012 after a review of 208 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Integra Spine (Integra Lifesciences) devices

FDA 510(k) Submission Details - K112986

510(k) Number K112986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2011
Decision Date May 01, 2012
Days to Decision 208 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
86d slower than avg
Panel avg: 122d · This submission: 208d
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 685
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K112986.
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K121129 · Spineology, Inc. · Jun 2012
LUCENT OR LUCENT MAGNUM
K110632 · Spinal Elements, Inc. · May 2012
PLATEAU SPACER SYSTEM
K121116 · Life Spine · May 2012
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120063 · L & K Biomed Co., Ltd. · Apr 2012
CAPSTONE CONTROL SPINAL SYSTEM
K120368 · Medtronic Sofamor Danek USA, Inc. · Apr 2012
RELIANCE LUMBAR IBF SYSTEM
K113540 · Reliance Medical Systems, LLC · Mar 2012