510(k) Report

Devices descending from K962705

25 later devices reach Mli Modular Staple through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG201224—
+2K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts20234—
+2K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226—
+2K173693Orbitum Bone Staple Implant, X and VIOrthovestments, LLC20180—
+2K172205ExoToe StapleExotoe, LLC20180—
+2K151160Arcus Staple SystemNextremity Solutions, Inc.20151—
+2K131061Restore Bunion Correction SystemNextremity Solutions201315—
+2K130627Swing-Off ScrewAdvanced Interventional Technology, LLC20130—
+3K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+3K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+3K210456Ligament StapleMedacta International S.A.20210—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—