510(k) Report

Devices descending from K031181

24 later devices reach External Fixation Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+1K163656Hoffmann LRF SystemStryker GmbH2017115
+1K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH2016132
+1K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG201414—
+1K130907Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG201315—
+1K130334Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG201315—
+1K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+1K113327Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp.2012173
+1K100795Jet-X Bar System Clamps and Posts ReprocessingSmith & Nephew, Inc.20100—
+2K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+2K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+2K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+2K182968Hoffmann LRF SystemStryker GmbH201910—
+2K161753Hoffman LRF SystemStryker GmbH201612—
+3K253291Excelsior SystemBlue Ocean Global20260—
+3K253202Hoffmann LRF SystemStryker GmbH20250—
+3K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+3K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+3K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+3K203568Hoffmann LRF SystemStryker GmbH20218—
+4K233741Hoffmann LRF SystemStryker GmbH20231—
+4K212895Paragon 28 External Ring Fixation SystemParagon 28, Inc.20215—
+5K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.20250—
+5K232838Monkey RingsTM External Fixation SystemParagon 28, Inc.20233—