Cleared Traditional

K133947 - IRIX-A LUMBAR INTEGRATED FUSION SYSTEM

K133947 is an FDA 510(k) clearance for IRIX-A LUMBAR INTEGRATED FUSION SYSTEM, manufactured by X-Spine Systems, Inc.. The device is a Class 2 Orthopedic device with product code OVD cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K133947 · X-Spine Systems, Inc. · Orthopedic device
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Jul 2014
Decision
218d
Days
Class 2
Risk

K133947 is an FDA 510(k) clearance for the IRIX-A LUMBAR INTEGRATED FUSION SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by X-Spine Systems, Inc. (Miamisburg, US). The FDA issued a Cleared decision on July 29, 2014 after a review of 218 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 X-Spine Systems, Inc. devices

FDA 510(k) Submission Details - K133947

510(k) Number K133947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2013
Decision Date July 29, 2014
Days to Decision 218 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 122d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 198
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K133947.
MIDLINE II TI
K141942 · Centinel Spine, Inc. · Nov 2014
RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K142095 · Renovis Surgical Technologies, Inc. · Oct 2014
BIOMET FUSION SYSTEM
K141791 · Biomet Spine · Oct 2014
COROENT XL-F SYSTEM
K140479 · Nu Vasive, Incorporated · Jul 2014
CHESAPEAKE SPINAL SYSTEM
K133494 · K2m, Inc. · Jun 2014
AERO-AL LUMBAR CAGE SYSTEM
K133328 · Stryker Corporation · May 2014