Cleared Traditional

K212715 - Vy Spine ClariVy Cervical IBF System

K212715 is the FDA 510(k) clearance for Vy Spine ClariVy Cervical IBF System by Vy Spine, LLC. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K212715 · Vy Spine, LLC · Orthopedic device
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Dec 2021
Decision
116d
Days
Class 2
Risk

K212715 is an FDA 510(k) clearance for the Vy Spine ClariVy 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 December 20, 2021 after a review of 116 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 Vy Spine, LLC devices

Submission Details

510(k) Number K212715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2021
Decision Date December 20, 2021
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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 K212715.
Peridot Spinal Interbody System
K213980 · Gbs Commonwealth Co., Ltd. · Mar 2022
Fortilink with TiPlus Technology
K213493 · Paradigm Spine · Jan 2022
FIX-C PEEK Anterior Cervical Interbody System
K212266 · Jeil Medical Corporation · Dec 2021
CHENA-C Spacer System
K213115 · Kahtnu Surgical, Inc. · Dec 2021
ORIO-Ti Intervertebral Body Fusion Cage System
K211935 · Spinecraft, LLC · Sep 2021
Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K212792 · Medynus, Inc. · Sep 2021