Cleared Special

Idys® C ZP 3DTi (K240715) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240715 · Clariance · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
7d
Days
Class 2
Risk

K240715 is an FDA 510(k) clearance for the Idys® C ZP 3DTi. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Clariance (Beaurains, FR). The FDA issued a Cleared decision on March 22, 2024 after a review of 7 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Clariance devices

Submission Details

510(k) Number K240715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2024
Decision Date March 22, 2024
Days to Decision 7 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
115d faster than avg
Panel avg: 122d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 93
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K240715.
Stable-C Interbody System
K241467 · Nexus Spine, LLC · Jul 2024
SCARLET® AC-Ti
K240699 · Spineart SA · May 2024
UniSpace® Stand-Alone C Cage
K234119 · Innosys Co., Ltd. · Apr 2024
Genesys Spine 3DP AIS-C II Cervical Interbody System
K233594 · Genesys Spine · Dec 2023
Shoreline ACS Interbody System
K233414 · SeaSpine Orthopedics Corporation · Nov 2023
TotalTi ACDF by SAGICO
K233191 · Spinal Analytics & Geometrical Implant Co, LLC · Nov 2023