Cleared Traditional

K193308 - T2 Alpha Tibia Nailing System

K193308 is the FDA 510(k) clearance for T2 Alpha Tibia Nailing System by Stryker Trauma GmbH. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K193308 · Stryker Trauma GmbH · Orthopedic device
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Feb 2020
Decision
86d
Days
Class 2
Risk

K193308 is an FDA 510(k) clearance for the T2 Alpha Tibia Nailing System, IMN Screws System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Stryker Trauma GmbH (Mahwah, US). The FDA issued a Cleared decision on February 23, 2020 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Trauma GmbH devices

Submission Details

510(k) Number K193308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2019
Decision Date February 23, 2020
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 326
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K193308.
PRECICE Bone Transport System
K193016 · Nuvasive Specialized Orthopedics, Inc. · May 2020
Precice® Screws
K193617 · Nuvasive Specialized Orthopedics, Inc. · May 2020
Affixus(R) Natural Nail(R) System Humeral Nail
K200814 · Zimmer GmbH · Apr 2020
TTC Phantom® Intramedullary Nail System
K192163 · Paragon 28, Inc. · Jan 2020
EBA One Nailing System
K183666 · Citieffe S.R.L. · Nov 2019
Zimmer Natural Nail System Cephalomedullary Nails
K192312 · Zimmer GmbH · Oct 2019