510(k) Report

Devices descending from K140738

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+1K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+1K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+1K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+1K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+1K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+1K202771CD Horizon Spinal SystemMedtronic202021—
+1K180376K2M Patient Specific RodsK2m, Inc.20182—
+1K150049PASS LP Spinal SystemMedicrea International20150—
+2K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+2K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+2K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+2K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+2K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+2K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+2K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+2K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+2K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+2K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+2K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+2K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+2K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+2K210306GII Spinal Fixation SystemColigne AG20210—
+3K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—