Cleared Special

K140106 - S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM

K140106 is an FDA 510(k) clearance for S128 ANTERIOR LUMBAR INTERBODY FUSION (..., manufactured by Renovis Surgical Technologies, Inc.. The device is a Class 2 Orthopedic device with product code OVD cleared through the Special 510(k) pathway after a 71-day FDA review.

K140106 · Renovis Surgical Technologies, Inc. · Orthopedic device
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Mar 2014
Decision
71d
Days
Class 2
Risk

K140106 is an FDA 510(k) clearance for the S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Renovis Surgical Technologies, Inc. (Ashland, US). The FDA issued a Cleared decision on March 27, 2014 after a review of 71 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Renovis Surgical Technologies, Inc. devices

FDA 510(k) Submission Details - K140106

510(k) Number K140106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2014
Decision Date March 27, 2014
Days to Decision 71 days
Submission Type Special
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
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 196
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K140106.
CHESAPEAKE SPINAL SYSTEM
K133494 · K2m, Inc. · Jun 2014
AERO-AL LUMBAR CAGE SYSTEM
K133328 · Stryker Corporation · May 2014
PROPOSED OPTIMUS
K132596 · Custom Spine, Inc. · Apr 2014
MIDLINE (TM)
K133286 · Centinel Spine, Inc. · Jan 2014
LATERAL SYNFIX
K131276 · Synthes USA Products, LLC · Jan 2014
MONUMENT SPACERS
K132559 · Globus Medical, Inc. · Dec 2013