510(k) Report

Devices descending from K112736

25 later devices reach Pass LP Spinal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA20222—
+1K143350Nile Alternative FixationK2m, Inc.201510—
+1K133482Silc Fixation SystemGlobus Medical, Inc.201411—
+1K132395LigapassMedicrea International201323—
+2K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+2K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+2K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+2K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+2K160698LigaPASSMedicrea International SA201612—
+2K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K172021LigaPASSMedicrea International SA201711—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K173506LigaPASSMedicrea International SA20189—
+5K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+5K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+6K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—