Cleared Special

K191271 - T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System

K191271 is an FDA 510(k) clearance for T2 Alpha Femur Antegrade GT/PF Nailing ..., manufactured by Stryker Trauma GmbH. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 29-day FDA review.

K191271 · Stryker Trauma GmbH · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
29d
Days
Class 2
Risk

K191271 is an FDA 510(k) clearance for the T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System,.... Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Stryker Trauma GmbH (Schoenkirchen, DE). The FDA issued a Cleared decision on June 11, 2019 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 - K191271

510(k) Number K191271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2019
Decision Date June 11, 2019
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 530
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K191271.
Syntec Tibial Nail System
K191617 · Syntec Scientific Corporation · Sep 2019
AOS ES Retrograde Femoral Nail
K191598 · Advanced Orthopaedic Solutions, Inc. · Jul 2019
Zimmer Guide Wire Devices
K191238 · Zimmer, Inc. · Jul 2019
Syntec Femoral Nail System
K181296 · Syntec Scientific Corporation · Apr 2019
PRECICE® BONE TRANSPORT™ System
K182170 · Nuvasive Specialized Orthopedics, Inc. · Feb 2019
Estremo Citieffe Nailing System
K181540 · Citieffe S.R.L. · Jan 2019
K191271 · T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
Download PDF FDA Summary Stryker Trauma GmbH