510(k) Report

Devices descending from K092190

14 later devices reach Synthes Distraction Osteogenesis System, MR Conditional with Expanded… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171911Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc.20170—
+1K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+1K113695Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc.201232
+2K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+2K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+2K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+2K191241AutoStrutOrthospin20194—
+2K141447Precice Trauma Nail SystemEllipse Technologies, Inc.20142—
+3K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+3K253202Hoffmann LRF SystemStryker GmbH20250—
+3K202810AutoStrut G2Orthospin, Ltd.20213—
+3K142599PRECISE Trauma Nail SystemEllipse Technologies, Incorporated20151—
+4K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+4K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated20150—