Cleared Traditional

K171496 - Tritanium C Anterior Cervical Cage

K171496 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 107-day FDA review.

K171496 · Stryker Spine · Orthopedic device
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Sep 2017
Decision
107d
Days
Class 2
Risk

K171496 is an FDA 510(k) clearance for the Tritanium C Anterior Cervical Cage. 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 September 6, 2017 after a review of 107 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 Stryker Spine devices

Submission Details

510(k) Number K171496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2017
Decision Date September 06, 2017
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K171496.
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Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
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K162496 · Corelink, LLC · May 2017