510(k) Report

Devices descending from K161129

19 later devices reach Pillar SA PTC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+1K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+1K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+2K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+2K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+3K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+3K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+3K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+4K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+4K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—