Cleared Special

K200613 - Tritanium® X TL Expandable Curved Posterior Lumbar Cage

K200613 is an FDA 510(k) clearance for Tritanium X TL Expandable Curved Poster..., manufactured by Stryker Corporation. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 37-day FDA review.

K200613 · Stryker Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
37d
Days
Class 2
Risk

K200613 is an FDA 510(k) clearance for the Tritanium® X TL Expandable Curved Posterior Lumbar 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 Corporation (Allendale, US). The FDA issued a Cleared decision on April 15, 2020 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K200613

510(k) Number K200613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2020
Decision Date April 15, 2020
Days to Decision 37 days
Submission Type Special
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
85d faster than avg
Panel avg: 122d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

MAX Device Classification - Class 2, Special Controls

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 898
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K200613.
AUDERE Lumbar Spacer System
K193457 · Met One Technologies · May 2020
SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
K200816 · Spineex, Inc. · Apr 2020
SeaSpine Reef TH System
K193636 · SeaSpine Orthopedics Corporation · Apr 2020
COMET Lumbar Interbody Fusion Cage
K191353 · Baui Biotech Co., Ltd. · Apr 2020
SIRION Lateral Lumbar Interbody System
K192006 · Astura Medical, LLC · Apr 2020
EVOS Lumbar Interbody System
K200552 · Cutting Edge Spine, LLC · Apr 2020
K200613 · Tritanium® X TL Expandable Curved Posterior Lumbar Cage
Download PDF FDA Summary Stryker Corporation