Cleared Traditional

K221490 - Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer (FDA 510(k) Clearance)

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

K221490 · Stryker Spine · Orthopedic device

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Optimized for regulatory review, auditing and printing

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.

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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.