Cleared Traditional

K143126 - Renovis S141 Lumbar Interbody Cage System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K143126 is an FDA 510(k) clearance for the Renovis S141 Lumbar Interbody Cage System. This device is classified as a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II - Special Controls, product code MAX).

Submitted by Renovis Surgical Technologies (Redlands, US). The FDA issued a Cleared decision on February 6, 2015, 98 days after receiving the submission on October 31, 2014.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..

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
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 116d · 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 96
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K143126.
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