510(k) Report

Devices descending from K103705

219 later devices reach Low Profile Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—