510(k) Report

Devices descending from K083654

12 later devices reach Zimmer Universal Locking System 2.7 MM Locking Plates and Screws ( Tivanium… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+1K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+2K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+2K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+2K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+2K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+4K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+5K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—