Cleared Traditional

K180436 - T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System

K180436 is an FDA 510(k) clearance for T2 Alpha Tibia Nailing System, manufactured by Stryker Trauma GmbH. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K180436 · Stryker Trauma GmbH · Orthopedic device
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Jun 2018
Decision
106d
Days
Class 2
Risk

K180436 is an FDA 510(k) clearance for the T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF 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 6, 2018 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Trauma GmbH devices

FDA 510(k) Submission Details - K180436

510(k) Number K180436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2018
Decision Date June 06, 2018
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K180436.
OIC Intramedullary Nail System
K181184 · The Orthopaedic Implant Company · Jul 2018
Arthrex FibuLock Nail
K173656 · Arthrex, Inc. · Jul 2018
Apex Femoral Nailing System
K181375 · Orthoxel · Jul 2018
OrthoPediatrics PediNail Intramedullary Platform
K172583 · Orthopediatrics, Inc. · May 2018
Agile Nail
K172699 · Orthofix Srl · Apr 2018
PRECICE STRYDE System
K180503 · Nuvasive Specialized Orthopedics, Inc. · Apr 2018