510(k) Report

Devices descending from K200052

13 later devices reach CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+1K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+1K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+1K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+2K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+2K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—