Cleared Traditional

Neo Cage System (K191796) - FDA 510(k) Clearance

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

K191796 · Neo Medical SA · Orthopedic device
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Dec 2019
Decision
163d
Days
Class 2
Risk

K191796 is an FDA 510(k) clearance for the Neo Cage 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 Neo Medical SA (Villette (Lavaux), CH). The FDA issued a Cleared decision on December 13, 2019 after a review of 163 days - an extended review 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: 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 Neo Medical SA devices

Submission Details

510(k) Number K191796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2019
Decision Date December 13, 2019
Days to Decision 163 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 slower than avg
Panel avg: 122d · This submission: 163d
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

Confinis Corporation
Charles Cathlin

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 464
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K191796.
Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
K192718 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Dec 2019
Pantheon Spinal Pontus Interbody Fusion Device
K181548 · Pantheon Spinal · Dec 2019
Keos Lumbar IBFD
K193174 · Keos · Dec 2019
Genesys Spine 3DP Lumbar Interbody System
K182987 · Genesys Spine · Dec 2019
SeaSpine Beachside System
K192132 · SeaSpine Orthopedics Corporation · Dec 2019
Peridot Intervertebral body fusion System
K192026 · Gbs Commonwealth Co., Ltd. · Nov 2019