510(k) Report

Devices descending from K212692

46 later devices reach Mariner Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+1K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+1K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+1K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+1K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+2K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+2K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+2K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+2K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+2K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+2K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+2K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+2K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+2K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+2K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+2K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+2K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+3K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—