510(k) Report

Devices descending from K052201

36 later devices reach Solanas Posterior Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133214Blackbird Spinal SystemChoicespine, LP20143—
+1K131119Solanas Posterior Stabilization SystemAlphatec Spine, Inc.201301
+1K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC20124—
+1K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+1K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+1K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+1K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+1K071380Modification to Solanas Posterior Stabilization SystemAlphatec Spine, Inc.2007183
+2K220025ARx® Spinal SystemLife Spine, Inc.20220—
+2K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+2K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+2K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+2K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+2K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+2K140734Nextgen Altius Oct SystemEbi, LLC20140—
+2K131427LOTUSSpinal Elements, Inc.20130—
+2K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+2K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+2K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+2K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+3K223852VySpan™ PCT SystemVy Spine, LLC20231—
+3K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+3K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+4K232167VySpan™ PCT SystemVy Spine, LLC20230—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200896Solstice CCILife Spine, Inc.20200—
+4K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—