510(k) Report

Devices descending from K132395

23 later devices reach Ligapass through their predicates, nearest generation first.

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