Cleared Traditional

K113527 - OPTICAGE INTERBODY FUSION DEVICE

K113527 is an FDA 510(k) clearance for OPTICAGE INTERBODY FUSION DEVICE, manufactured by Interventional Spine, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K113527 · Interventional Spine, Inc. · Orthopedic device
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Jan 2012
Decision
51d
Days
Class 2
Risk

K113527 is an FDA 510(k) clearance for the OPTICAGE 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 Interventional Spine, Inc. (Irvine, US). The FDA issued a Cleared decision on January 20, 2012 after a review of 51 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Interventional Spine, Inc. devices

FDA 510(k) Submission Details - K113527

510(k) Number K113527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2011
Decision Date January 20, 2012
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
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 661
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K113527.
MECTALIF TRANSFORAMINAL
K120024 · Medacta International S.A. · Feb 2012
SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
K113030 · Spineology, Inc. · Jan 2012
RISE SPACER
K113447 · Globus Medical, Inc. · Jan 2012
ALEUTIAN SYSTEM
K113138 · K2m, Inc. · Jan 2012
CLYDESDALE(R) SPINAL SYSTEM
K113528 · Medtronic Sofamor Danek USA, Inc. · Dec 2011
CLYDESDALES SPINAL SYSTEM
K112405 · Medtronic Sofamor Danek USA, Inc. · Nov 2011