510(k) Report

Devices descending from K121277

24 later devices reach Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple through their predicates, nearest generation first.

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