510(k) Report

Devices descending from K161417

8 later devices reach DePuy Synthes MAXFRAME Multi-Axial Correction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+1K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+1K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+1K191241AutoStrutOrthospin20194—
+2K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+2K253202Hoffmann LRF SystemStryker GmbH20250—
+2K202810AutoStrut G2Orthospin, Ltd.20213—
+3K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—