Cleared Special

K153415 - Reprocessed Stryker External Fixation D...

K153415 is an FDA 510(k) clearance for Reprocessed Stryker External Fixation D..., manufactured by Stryker Sustainability Solutions. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 49-day FDA review.

K153415 · Stryker Sustainability Solutions · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
49d
Days
Class 2
Risk

K153415 is an FDA 510(k) clearance for the Reprocessed Stryker External Fixation Devices. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on January 13, 2016 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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.

View all Stryker Sustainability Solutions devices

FDA 510(k) Submission Details - K153415

510(k) Number K153415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2015
Decision Date January 13, 2016
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 298
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K153415.
Hoffmann LRF System
K163656 · Stryker GmbH · Apr 2017
Hoffman LRF System
K161753 · Stryker GmbH · Nov 2016
Hoffmann LRF (Limb Reconstruction Frame) System
K153377 · Stryker GmbH · Apr 2016
SALVATION(R) External Fixation System
K153635 · Wrightmedicaltechnologyinc · Jan 2016
Galaxy UNYCO System
K153233 · Orthofix Srl · Jan 2016
Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables
K151907 · Zimmer, Inc. · Dec 2015