Cleared Traditional

ADI Cervical Interbody Fusion Device (K191812) - FDA 510(k) Clearance

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

K191812 · Additive Device, Inc. (Adi) D/B/A Restor3D · Orthopedic device
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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 347
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K191812.
BluEX Cervical Expandable Cage System
K260840 · L & K Biomed Co., Ltd. · May 2026
OSTEOMNI SPINAL CAGES SYSTEM
K260850 · OSTEOMNI, Inc. · May 2026
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
K260549 · Zsfab, Inc. · Apr 2026
ORIO-3D Cage System
K253260 · SpineCraft · Apr 2026
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
K260340 · HC Biologics, LLC · Apr 2026
MOD-C
K242303 · Orthomod, LLC · Apr 2026