Cleared Traditional

K123969 - XIPHOS

K123969 is the FDA 510(k) clearance for XIPHOS by Difusion Technologies. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K123969 · Difusion Technologies · Orthopedic device
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Feb 2013
Decision
43d
Days
Class 2
Risk

K123969 is an FDA 510(k) clearance for the XIPHOS. 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 Difusion Technologies (Chesterland, US). The FDA issued a Cleared decision on February 7, 2013 after a review of 43 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 Difusion Technologies devices

Submission Details

510(k) Number K123969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2012
Decision Date February 07, 2013
Days to Decision 43 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
79d faster than avg
Panel avg: 122d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 577
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K123969.
ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST
K122037 · Medtronic Sofamor Danek, Inc. · Mar 2013
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K123652 · Spineology, Inc. · Mar 2013
LUCENT
K122967 · Spinal Elements, Inc. · Feb 2013
CALIBER SPACERS
K123231 · Globus Medical, Inc. · Jan 2013
FALCON SPACER
K123180 · Synthes USA Products, LLC · Jan 2013
PATRIOT SPACERS
K122097 · Globus Medical, Inc. · Dec 2012