Cleared Traditional

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System

K213328 · Stryker GmbH · Orthopedic
Feb 2022
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K213328 is an FDA 510(k) clearance for the Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Stryker GmbH (Malwah, US). The FDA issued a Cleared decision on February 11, 2022, 129 days after receiving the submission on October 5, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K213328 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2021
Decision Date February 11, 2022
Days to Decision 129 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