Cleared Traditional

K221490 - Tritanium C Anterior Cervical Cage

K221490 is the FDA 510(k) clearance for Tritanium C Anterior Cervical Cage by Stryker Spine. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K221490 · Stryker Spine · Orthopedic device
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Feb 2023
Decision
267d
Days
Class 2
Risk

K221490 is an FDA 510(k) clearance for the Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Po.... Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on February 14, 2023 after a review of 267 days - an extended review cycle.

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 Stryker Spine devices

Submission Details

510(k) Number K221490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2022
Decision Date February 14, 2023
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
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 218
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K221490.
The Integrity Spine Core System
K223043 · Integrity Spine · Mar 2023
Ti-Largo Cervical Interbody System
K223231 · Flospine · Feb 2023
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
K213755 · Gbs Commonwealth Co., Ltd. · Feb 2023
Curiteva Porous PEEK Cervical Interbody Fusion System
K213030 · Curiteva, Inc. · Feb 2023
Eminent Spine 3D Cervical Interbody Fusion System
K212701 · Eminent Spine · Feb 2023
Manta Ray TDF Spacer
K220296 · SeaSpine Orthopedics Corporation · Feb 2023