Cleared Traditional

K111123 - VARILIFT CERVICAL INTERBODY FUSION SYSTEM

K111123 is an FDA 510(k) clearance for VARILIFT CERVICAL INTERBODY FUSION SYSTEM, manufactured by Wenzel Spine. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K111123 · Wenzel Spine · Orthopedic device
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Dec 2011
Decision
231d
Days
Class 2
Risk

K111123 is an FDA 510(k) clearance for the VARILIFT CERVICAL INTERBODY FUSION SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Wenzel Spine (Round Rock, US). The FDA issued a Cleared decision on December 8, 2011 after a review of 231 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 Wenzel Spine devices

FDA 510(k) Submission Details - K111123

510(k) Number K111123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2011
Decision Date December 08, 2011
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 256
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K111123.
DEPUY PULSE CERVICAL CAGE SYSTEM
K120517 · Medos International SARL · Apr 2012
ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K113518 · Spinefrontier, Inc. · Feb 2012
MECTA-C
K112862 · Medacta International · Dec 2011
TRABECULAR METAL (TM) FUSION DEVICE
K111119 · Zimmer Spine, Inc. · Nov 2011
CALIX PC SPINAL IMPLANT SYSTEM
K112036 · X-Spine Systems, Inc. · Nov 2011
PERIMETER C SPINAL SYSTEM
K100967 · Medtronic Sofamor Danek USA, Inc. · Aug 2011