510(k) Report

Devices descending from K081546

116 later devices reach Small Bone Locking Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+7K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+8K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—