Cleared Special

K223513 - UniVy™ OsteoVy™-Ti Cervical IBF System

K223513 is an FDA 510(k) clearance for UniVy OsteoVy-Ti Cervical IBF System, manufactured by Vy Spine, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 147-day FDA review.

K223513 · Vy Spine, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
147d
Days
Class 2
Risk

K223513 is an FDA 510(k) clearance for the UniVy™ OsteoVy™-Ti Cervical IBF System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Vy Spine, LLC (Tallahassee, US). The FDA issued a Cleared decision on April 18, 2023 after a review of 147 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K223513

510(k) Number K223513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2022
Decision Date April 18, 2023
Days to Decision 147 days
Submission Type Special
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
25d slower than avg
Panel avg: 122d · This submission: 147d
Pathway characteristics
Modification to existing cleared device.

ODP Device Classification - Class 2, Special Controls

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 352
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K223513.
INTEGRATE -C Interbody Fusion System
K222004 · Happe Spine · Apr 2023
NITRO Interbody Fusion Cage System Family
K220513 · Ctl Medical Corporation · Apr 2023
NEST-C Interbody System
K220261 · Paonan Biotech Co., Ltd. · Apr 2023
SQUALE
K230026 · Implanet, S.A. · Mar 2023
Tryptik Ti
K230583 · Spineart SA · Mar 2023
The Integrity Spine Core System
K223043 · Integrity Spine · Mar 2023
K223513 · UniVy™ OsteoVy™-Ti Cervical IBF System
Download PDF FDA Summary Vy Spine, LLC