510(k) Report

Devices descending from K990094

127 later devices reach Kmi Wrist Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+6K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+6K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+6K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—