Cleared Traditional

K143126 - Renovis S141 Lumbar Interbody Cage System

K143126 is the FDA 510(k) clearance for Renovis S141 Lumbar Interbody Cage System by Renovis Surgical Technologies. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K143126 · Renovis Surgical Technologies · Orthopedic device
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Feb 2015
Decision
98d
Days
Class 2
Risk

K143126 is an FDA 510(k) clearance for the Renovis S141 Lumbar Interbody Cage System. 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 Renovis Surgical Technologies (Redlands, US). The FDA issued a Cleared decision on February 6, 2015 after a review of 98 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 K143126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2014
Decision Date February 06, 2015
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 596
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K143126.
AccuLIF TL and PL Cage
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K150285 · Spine Wave, Inc. · Mar 2015
Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)
K143297 · Zimmer Spine, Inc. · Feb 2015
LEVA (TM) SPACER SYSTEM
K141980 · Spine Wave, Inc. · Jan 2015
JULIET LL
K141135 · Spineart · Dec 2014
COROENT SYSTEM
K141896 · Nu Vasive, Incorporated · Nov 2014