Cleared Special

K223510 - Matrix HA Fusion Porous Cervical IBF System

K223510 is an FDA 510(k) clearance for Matrix HA Fusion Porous Cervical IBF System, manufactured by Innovasis, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 20-day FDA review.

K223510 · Innovasis, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
20d
Days
Class 2
Risk

K223510 is an FDA 510(k) clearance for the Matrix HA Fusion Porous Cervical IBF System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 12, 2022 after a review of 20 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.

FDA 510(k) Submission Details - K223510

510(k) Number K223510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2022
Decision Date December 12, 2022
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
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 K223510.
NuVasive Modulus-C Interbody System
K223731 · Nuvasive, Inc. · Jan 2023
Cervical Spine Truss System (CSTS) Interbody Fusion Device
K221266 · 4Web Medical, Inc. · Jan 2023
Kodiak C Spinal Implant System
K222806 · Met One Technologies, LLC · Dec 2022
IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem
K222973 · Alphatec Spine, Inc. · Nov 2022
UniVy OsteoVy Cervical IBF System
K221162 · Vy Spine, LLC · Nov 2022
HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments
K222270 · Globus Medical, Inc. · Oct 2022
K223510 · Matrix HA Fusion Porous Cervical IBF System
Download PDF FDA Summary Innovasis, Inc.