510(k) Report

Devices descending from K051942

81 later devices reach Malibu Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+1K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+1K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+1K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+1K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+1K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+1K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+1K072605Malibu Spinal SystemSeaspine, Inc.200767—
+1K061342Malibu Spinal SystemSeaspine, Inc.2006801
+2K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+2K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+2K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+2K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+2K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+2K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+2K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+2K120047Coral Spinal SystemTheken Spine, LLC201214—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+3K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+3K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+3K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+3K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+3K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+3K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+3K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+4K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+5K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K252322SIros-X SystemGenesys Spine20250—
+6K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—