Cleared Traditional

K222833 - Ventana C Spinal System

K222833 is the FDA 510(k) clearance for Ventana C Spinal System by Spinal Elements, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K222833 · Spinal Elements, Inc. · Orthopedic device
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May 2023
Decision
241d
Days
Class 2
Risk

K222833 is an FDA 510(k) clearance for the Ventana™ C Spinal System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 19, 2023 after a review of 241 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 Spinal Elements, Inc. devices

Submission Details

510(k) Number K222833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2022
Decision Date May 19, 2023
Days to Decision 241 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
119d slower than avg
Panel avg: 122d · This submission: 241d
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 215
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K222833.
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
ClariVy™ Cervical IBF System
K230414 · Vy Spine, LLC · May 2023
INTEGRATE -C Interbody Fusion System
K222004 · Happe Spine · Apr 2023
NITRO Interbody Fusion Cage System Family
K220513 · Ctl Medical Corporation · Apr 2023