Cleared Traditional

K131365 - T2 TIBIAL NAILING SYSTEM

K131365 is an FDA 510(k) clearance for T2 TIBIAL NAILING SYSTEM, manufactured by Stryker Trauma AG. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K131365 · Stryker Trauma AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
150d
Days
Class 2
Risk

K131365 is an FDA 510(k) clearance for the T2 TIBIAL NAILING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Stryker Trauma AG (Mahwah, US). The FDA issued a Cleared decision on October 10, 2013 after a review of 150 days - an extended review 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: 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 AG devices

FDA 510(k) Submission Details - K131365

510(k) Number K131365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2013
Decision Date October 10, 2013
Days to Decision 150 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
28d slower than avg
Panel avg: 122d · This submission: 150d
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 365
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K131365.
SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
K131548 · Synthes USA Products, LLC · Feb 2014
TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N
K133081 · Advanced Orthopaedic Solutions, Inc. · Dec 2013
AEQUALIS HUMERAL NAIL
K133376 · Tornier, Inc. · Dec 2013
PICCOLO COMPOSITE NAILING SYSTEM
K132774 · CarboFix Orthopedics , Ltd. · Oct 2013
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
K130595 · Zimmer, Inc. · Sep 2013
RETROGRADE FEMORAL NAIL
K132005 · Advanced Orthopaedic Solutions, Inc. · Sep 2013