Cleared Traditional

K180502 - S128 Anterior Lumbar Interbody Fusion (...

K180502 is the FDA 510(k) clearance for S128 Anterior Lumbar Interbody Fusion (... by Renovis Surgical Technologies, Inc.. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K180502 · Renovis Surgical Technologies, Inc. · Orthopedic device
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Jun 2018
Decision
108d
Days
Class 2
Risk

K180502 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. (Redlands, US). The FDA issued a Cleared decision on June 14, 2018 after a review of 108 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, Inc. devices

Submission Details

510(k) Number K180502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2018
Decision Date June 14, 2018
Days to Decision 108 days
Submission Type Traditional
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
14d faster than avg
Panel avg: 122d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

MEDIcept, Inc.
Sharyn Orton

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 147
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K180502.
NuVasive Brigade Lateral System
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K173432 · Camber Spine Technologies · Apr 2018