Cleared Traditional

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System

K253640 · Stryker GmbH · Orthopedic
Feb 2026
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K253640 is an FDA 510(k) clearance for the T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Stryker GmbH (Selzach, Solothurn, Ch, CH). The FDA issued a Cleared decision on February 3, 2026, 76 days after receiving the submission on November 19, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K253640 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2025
Decision Date February 03, 2026
Days to Decision 76 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

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