Cleared Traditional

K170888 - Renovis S141 Lumbar Interbody Fusion Sy...

K170888 is the FDA 510(k) clearance for Renovis S141 Lumbar Interbody Fusion Sy... by Renovis Surgical Technologies. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K170888 · Renovis Surgical Technologies · Orthopedic device
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Aug 2017
Decision
134d
Days
Class 2
Risk

K170888 is an FDA 510(k) clearance for the Renovis S141 Lumbar Interbody Fusion 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 August 8, 2017 after a review of 134 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 K170888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2017
Decision Date August 08, 2017
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
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 K170888.
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
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ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
K172199 · Medtronic Sofamor Danek · Sep 2017
Duo Lumbar Interbody Fusion Device
K171660 · Spineology, Inc. · Aug 2017
The TiBow Expandable Spacer System
K170919 · Life Spine, Inc. · Aug 2017
Rampart L Lumbar Interbody Fusion Device
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CONCORDE LIFT
K171425 · Medos International SARL · Jul 2017