Home / 510(k) Clearances / K251400

510(k) K251400

T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System by Stryker GmbH — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2025
Date Received
May 6, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Stryker GmbH

  • K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (February 3, 2026)
  • K253202 — Hoffmann LRF System (December 19, 2025)
  • K250163 — T2 Alpha Femur Retrograde Nailing System (August 13, 2025)
  • K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pan (October 6, 2024)
  • K233919 — VariAx 2 Distal Radius System (March 25, 2024)
  • K233741 — Hoffmann LRF System (December 21, 2023)
  • K230045 — HipCheck (September 29, 2023)
  • K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with (September 20, 2023)
  • K231257 — Pangea Utility Plating System, Pangea Platform (August 18, 2023)
  • K231262 — Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating (August 18, 2023)

Other clearances for product code HSB

  • K253566 — Affixus Retrograde Femoral Nailing System (March 12, 2026)
  • K253517 — Reselute Tibial Nail (March 10, 2026)
  • K252196 — Arthrex FibuLock Nail System (March 5, 2026)
  • K253591 — Phantom® Hindfoot TTC/TC Nail System (March 5, 2026)
  • K252025 — Active Intramedullary (AIM) Tibial Nail System (March 4, 2026)
  • K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (February 3, 2026)
  • K253749 — Affixus® Natural Nail® Proximal Humeral System (December 12, 2025)
  • K252826 — ARIX Femur Nail System (December 10, 2025)
  • K250197 — Estremo Fibular Nail (October 17, 2025)
  • K250628 — DynaNail TTC Fusion System (September 12, 2025)