510(k) Report

Devices descending from K021321

113 later devices reach Wrist Fusion Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+7K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—