Cleared Traditional

K202190 - Oculus-SA Lumbar Cage System

K202190 is the FDA 510(k) clearance for Oculus-SA Lumbar Cage System by Neurostructures. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K202190 · Neurostructures · Orthopedic device
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Oct 2020
Decision
58d
Days
Class 2
Risk

K202190 is an FDA 510(k) clearance for the Oculus-SA Lumbar Cage System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Neurostructures (Irvine, US). The FDA issued a Cleared decision on October 2, 2020 after a review of 58 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 Neurostructures devices

Submission Details

510(k) Number K202190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2020
Decision Date October 02, 2020
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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

Empirical Testing Corp
Nathan Wright

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 141
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K202190.
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CORBEL Spacers
K201087 · Globus Medical, Inc. · Jul 2020
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K200002 · 4Web, Inc. · May 2020