FDA.reportPublic FDA data

510(k) K243798

Device
Orthex External Fixation System
Applicant
OrthoPediatrics Corp.
510(k) number
K243798
Product code
KTT
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-07
Date received
2024-12-11
Regulation
888.3030
Classification name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jessica Powers
Address
2850 Frontier Dr. Warsaw IN US 46582 46582

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KTT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260900DYNEX® External Fixation SystemsVilex, LLC2026-04-17
K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.2026-03-23
K253291Excelsior SystemBlue Ocean Global2026-01-20
K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.2025-12-19
K253202Hoffmann LRF SystemStryker GmbH2025-12-19
K252555Medusa Orthopedics Boa External Fixation SystemMedusa Orthopedics, LLC2025-11-25
K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC2025-11-20
K252106External Fixation Mini Rail SystemParagon 28, Inc.2025-09-30
K251862External Fixation Bone DistractorParagon 28, Inc.2025-08-11
K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.2025-08-08
K251128Extremity Medical External Fixation SystemExtremity Medical, LLC2025-05-07
K241563Extremity Medical External Fixation SystemExtremity Medical, LLC2025-02-21
K242861TrueLok ElevateOrthofix Srl2024-12-03
K242452Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc.2024-11-01
K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC2024-09-18