510(k) Report

Devices descending from K013888

315 later devices reach Fixation (Steinmann) Pins through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+8K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+8K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+9K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+9K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+9K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+9K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+10K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+10K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+10K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+11K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—