Cleared Traditional

K162262 - Tritanium PL Cage

K162262 is the FDA 510(k) clearance for Tritanium PL Cage by Stryker. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K162262 · Stryker · Orthopedic device
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Nov 2016
Decision
90d
Days
Class 2
Risk

K162262 is an FDA 510(k) clearance for the Tritanium® PL Cage. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Stryker (Allendale, US). The FDA issued a Cleared decision on November 9, 2016 after a review of 90 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.

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Submission Details

510(k) Number K162262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2016
Decision Date November 09, 2016
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 609
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K162262.
FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System
K162446 · Orthofix, Inc. · Dec 2016
COUGAR® LS Lateral Cage System and COUGAR® System
K162327 · Medos International SARL · Dec 2016
Xsert Lumbar Expandable Interbody System
K160959 · X-Spine Systems, Inc. · Nov 2016
Genesys Spine Apache® Anterior Lumbar Interbody Fusion System
K161438 · Genesys Spine · Nov 2016
T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
K162358 · Synthes USA Products, LLC · Nov 2016
SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene
K162715 · SeaSpine Orthopedics Corporation · Oct 2016