Cleared Traditional

Kodiak C Spinal Implant System (K222806) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222806 · Met One Technologies, LLC · Orthopedic device
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Dec 2022
Decision
97d
Days
Class 2
Risk

K222806 is an FDA 510(k) clearance for the Kodiak C Spinal Implant System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Met One Technologies, LLC (El Paso, US). The FDA issued a Cleared decision on December 22, 2022 after a review of 97 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 Met One Technologies, LLC devices

Submission Details

510(k) Number K222806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2022
Decision Date December 22, 2022
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
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 178
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K222806.
Manta Ray TDF Spacer
K220296 · SeaSpine Orthopedics Corporation · Feb 2023
NuVasive Modulus-C Interbody System
K223731 · Nuvasive, Inc. · Jan 2023
Cervical Spine Truss System (CSTS) Interbody Fusion Device
K221266 · 4Web Medical, Inc. · Jan 2023
Matrix HA Fusion Porous Cervical IBF System
K223510 · Innovasis, Inc. · 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