510(k) Report

Devices descending from K853033

696 later devices reach Hartshill Rect & Wires, Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+10K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+10K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K243249TriALTIS™ Spine SystemMedos International SARL20250—
+10K243693NEO Pedicle Screw System™Neo Medical SA20240—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+10K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+10K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K232628VADER® Pedicle SystemIcotec AG20241—
+10K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+10K233684TriALTIS™ Spine SystemMedos International SARL20234—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+10K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K223494CD Horizon Spinal SystemMedtronic202317—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+10K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+10K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+10K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+10K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+10K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+10K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+10K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+11K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+11K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+11K260546Q Pedicle InstrumentsK2m, Inc.20260—
+11K252873Q Interbody InstrumentsK2m, Inc.20260—
+11K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+11K253331PressON Spinal Fixation SystemNexus Spine20250—
+11K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+11K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+11K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+11K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+11K242042TriALTIS™ Spine SystemMedos International SARL20241—
+11K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+11K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+11K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+11K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+11K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+11K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+11K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+11K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+11K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+11K182470Plateau Spacer SystemLife Spine20180—
+11K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+12K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+12K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+12K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+12K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+12K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+12K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+12K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+12K232432E3D™-A Interbody SystemEvolution Spine20248—
+12K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+12K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+12K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+12K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+12K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+12K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+12K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+13K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+13K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+13K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+13K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+13K240368E3D™-A Interbody SystemEvolution Spine20247—
+13K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+13K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+13K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+13K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+13K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+13K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+14K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+14K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+14K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+14K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+14K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+14K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—