Cleared Traditional

K133514 - XCAGE INTERBODY FUSION SYSTEM

K133514 is an FDA 510(k) clearance for XCAGE INTERBODY FUSION SYSTEM, manufactured by Ouroboros Medical. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K133514 · Ouroboros Medical · Orthopedic device
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May 2014
Decision
167d
Days
Class 2
Risk

K133514 is an FDA 510(k) clearance for the XCAGE INTERBODY 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 Ouroboros Medical (Fremont, US). The FDA issued a Cleared decision on May 1, 2014 after a review of 167 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. 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 Ouroboros Medical devices

FDA 510(k) Submission Details - K133514

510(k) Number K133514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2013
Decision Date May 01, 2014
Days to Decision 167 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
45d slower than avg
Panel avg: 122d · This submission: 167d
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 K133514.
BN LUMBAR CAGE SYSTEM
K140564 · Medyssey USA, Inc. · Jun 2014
SKYHAWK INTERBODY FUSION SYSTEM
K140709 · Orthofix, Inc. · May 2014
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
K133418 · Seaspine, Inc. · May 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607 · Exactech, Inc. · Apr 2014
ANYPLUS
K131612 · GS Medical Co., Ltd. · Apr 2014
JULIET OL
K140474 · Spineart · Apr 2014