Cleared Traditional

K181655 - Renovis S180 Lateral Lumbar Interbody F...

K181655 is the FDA 510(k) clearance for Renovis S180 Lateral Lumbar Interbody F... by Renovis Surgical Technologies. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K181655 · Renovis Surgical Technologies · Orthopedic device
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Sep 2018
Decision
81d
Days
Class 2
Risk

K181655 is an FDA 510(k) clearance for the Renovis S180 Lateral 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 September 11, 2018 after a review of 81 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Renovis Surgical Technologies devices

Submission Details

510(k) Number K181655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2018
Decision Date September 11, 2018
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 595
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K181655.
Tranquil-L Interbody System
K181702 · Nexus Spine, LLC · Sep 2018
Sypher Spacer System
K181337 · Biogennix, LLC · Sep 2018
LnK Lumbar Interbody Fusion Cage System
K181380 · L & K Biomed Co., Ltd. · Sep 2018
Tranquil Interbody System
K181483 · Nexus Spine, LLC · Aug 2018
CancelleX Porous Titanium Lumbar Interbody Device
K180373 · Xenco Medical, LLC · Aug 2018
Aries® Lumbar Interbodies
K181347 · Osseus Fusion Systems, LLC · Aug 2018