510(k) Report

Devices descending from K963433

317 later devices reach Threaded Fixation Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—