Cleared Traditional

TRIGEN META-TAN Trochanteric Antegrade Nail

K243364 · Smith & Nephew, Inc. · Orthopedic
Dec 2024
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K243364 is an FDA 510(k) clearance for the TRIGEN META-TAN Trochanteric Antegrade Nail, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on December 9, 2024, 41 days after receiving the submission on October 29, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K243364 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2024
Decision Date December 09, 2024
Days to Decision 41 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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

Similar Devices — HSB Rod, Fixation, Intramedullary And Accessories

All 519
Affixus Retrograde Femoral Nailing System
K253566 · Zimmer, Inc. · Mar 2026
Reselute Tibial Nail
K253517 · Reselute, Inc. · Mar 2026
Arthrex FibuLock Nail System
K252196 · Arthrex, Inc. · Mar 2026
Phantom? Hindfoot TTC/TC Nail System
K253591 · Paragon 28, Inc. · Mar 2026
Active Intramedullary (AIM) Tibial Nail System
K252025 · Satori Orthopaedics, Inc. · Mar 2026
T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
K253640 · Stryker GmbH · Feb 2026

More from Smith & Nephew, Inc.

View all
AETOS Shoulder System Meta Humeral Prosthesis Size 0
K252416 · KWS · Oct 2025
AETOS Shoulder System Stemless Humeral Prosthesis
K252129 · PKC · Oct 2025
BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)
K251627 · MBI · Jun 2025
TRIGEN Stable Lock Nut & Washer
K243608 · JDS · Jun 2025
LEGION Total Knee System
K250677 · JWH · Apr 2025