FDA.reportPublic FDA data

510(k) K261481

Device
Pangea Femur Reconstruction System
Applicant
Stryker GmbH
510(k) number
K261481
Product code
HSB
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-29
Date received
2026-05-05
Regulation
888.3020
Classification name
Rod, Fixation, Intramedullary And Accessories
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Megan DenBleyker
Address
Bohnackerweg 1 Selzach CH 2545 2545

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HSB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics2026-06-18
K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.2026-06-18
K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.2026-06-17
K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.2026-06-16
K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl2026-05-19
K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl2026-05-08
K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.2026-04-24
K252016Arthrex Humeral NailsArthrex, Inc.2026-03-20
K252961Fusion FibFix NailFusion Orthopedics USA, LLC2026-03-18
K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.2026-03-12
K253517Reselute Tibial NailReselute, Inc.2026-03-10
K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.2026-03-05
K252196Arthrex FibuLock Nail SystemArthrex, Inc.2026-03-05
K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.2026-03-04
K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH2026-02-03