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FDA 510(k)

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System

K-Number: K253640 · 2026-02-03

ApplicantStryker GmbH
Decision Date2026-02-03
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2026-02-03 under approval number K253640. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System?

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System is a medical device that received FDA 510(k) clearance on 2026-02-03. It is manufactured by Stryker GmbH. The 510(k) number is K253640.

When was T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System approved by the FDA?

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System received FDA 510(k) clearance on 2026-02-03, under approval number K253640.

What company makes T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System?

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System is manufactured by Stryker GmbH.

What is the FDA product code for T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System?

The FDA product code for T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System is HSB.

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Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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