Cleared Traditional

K153250 - Renovis Tesera SC Stand-alone Anterior ...

K153250 is the FDA 510(k) clearance for Renovis Tesera SC Stand-alone Anterior ... by Renovis Surgical Technologies. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K153250 · Renovis Surgical Technologies · Orthopedic device
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Mar 2016
Decision
128d
Days
Class 2
Risk

K153250 is an FDA 510(k) clearance for the Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Renovis Surgical Technologies (Redlands, US). The FDA issued a Cleared decision on March 16, 2016 after a review of 128 days - within the typical 510(k) review window.

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 Renovis Surgical Technologies devices

Submission Details

510(k) Number K153250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2015
Decision Date March 16, 2016
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 113
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K153250.
Pro-Link® Stand-Alone Cervical Spacer System
K160066 · Life Spine, Inc. · Sep 2016
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
K153352 · Spinal Elements, Inc. · Aug 2016
Cervical Stand Alone System
K161280 · Orthofix, Inc. · Jun 2016
COALITION Spacers
K151939 · Globus Medical, Inc. · Jan 2016
SCARLET® AC-T Secured Anterior Cervical Cage
K143214 · Spineart · Feb 2015
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
K141599 · Medtronic Sofamor Danek USA, Inc. · Jan 2015