510(k) Report

Devices descending from K072981

546 later devices reach Synthes Zero-P through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+9K213417Ghost Spacer SystemLife Spine, Inc.20220—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+12K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+13K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—