Cleared Traditional

K222015 - Integral Titanium Cervical Interbody

K222015 is the FDA 510(k) clearance for Integral Titanium Cervical Interbody by Nvision Biomedical Technologies, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 362-day FDA review.

K222015 · Nvision Biomedical Technologies, Inc. · Orthopedic device
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Jul 2023
Decision
362d
Days
Class 2
Risk

K222015 is an FDA 510(k) clearance for the Integral Titanium Cervical Interbody. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Nvision Biomedical Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 5, 2023 after a review of 362 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nvision Biomedical Technologies, Inc. devices

Submission Details

510(k) Number K222015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2022
Decision Date July 05, 2023
Days to Decision 362 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
240d slower than avg
Panel avg: 122d · This submission: 362d
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 Consultant

Nvision Biomedical Technologies
Analaura Villarreal-Berain

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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K222015.
SPICCA Cervical Fusion Cages
K230607 · Southern Medical (Pty) , Ltd. · Aug 2023
CarboClear Cervical Cage System, CarboClear Cervical VBR System
K222874 · Carbofix Orthpedics , Ltd. · Jul 2023
NuVasive CoRoent Small Interbody System
K231735 · Nu Vasive, Incorporated · Jul 2023
F3D Interbody System
K230329 · Corelink, LLC · Jun 2023
Anatomic PEEK™ Cervical Fusion System with Nanotechnology
K230936 · Nanovis, LLC · Jun 2023
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)
K230708 · Gbs Commonwealth Co., Ltd. · May 2023