510(k) Report

Devices descending from K020522

1,234 later devices reach Modification to Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K173537Concorde Lift™Medos International SARL20181—
+7K172816TiGer Shark™ SystemChoicespine, LP201859—
+7K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+7K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+7K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+7K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K162262Tritanium® PL CageStryker2016132—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—
+7K160955Tritanium® PL CageStryker2016178—
+7K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+7K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+7K152651AccuLIF TL and PL CageStryker Corporation201530—
+7K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+7K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+7K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+7K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K263049SABER-C SystemElevation Spine20260—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+8K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+8K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+8K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+8K190680Favo S-TlifSilony Medical GmbH20190—
+8K182608Oyster ACIF CageSilony Medical GmbH20190—
+8K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+8K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+8K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K172756Varian cageMedyssey USA, Inc.20171—
+8K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+8K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+8K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+8K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+8K160715AccuLIF TL and PL CageStryker Corporation20160—
+8K141217Acculif TL and PL CageStryker Corporation20146423
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—