Cleared Traditional

K191812 - ADI Cervical Interbody Fusion Device

K191812 is the FDA 510(k) clearance for ADI Cervical Interbody Fusion Device by Additive Device, Inc. (Adi) D/B/A Restor3D. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K191812 · Additive Device, Inc. (Adi) D/B/A Restor3D · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
111d
Days
Class 2
Risk

K191812 is an FDA 510(k) clearance for the ADI Cervical Interbody Fusion Device. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Additive Device, Inc. (Adi) D/B/A Restor3D (Durham, US). The FDA issued a Cleared decision on October 24, 2019 after a review of 111 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 Additive Device, Inc. (Adi) D/B/A Restor3D devices

Submission Details

510(k) Number K191812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2019
Decision Date October 24, 2019
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 218
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K191812.
icotec Cervical Cage
K192897 · Icotec AG · Mar 2020
SureMAX Family of Cervical Spacers
K193359 · Additive Implants, Inc. · Jan 2020
4CIS Marlin PEEK ACIF Cage
K192044 · Solco Biomedical Co., Ltd. · Dec 2019
Matrix HA PEEK Cervical Implant System
K192316 · Sapphire Medical Group · Oct 2019
Nano FortiCore, FortiCore
K191822 · Nanovis, LLC · Oct 2019
CORNICE Cervical Spacer System
K192208 · Legend Spine Technologies · Oct 2019