510(k) Report

Devices descending from K962823

836 later devices reach Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242861TrueLok ElevateOrthofix Srl20243—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K230026SqualeImplanet, S.A.20230—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+7K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+7K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+7K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+7K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+7K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+7K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+7K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+7K102528N-Force Fixation SystemInnovision, Inc.20115—
+7K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+7K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+7K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+8K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+8K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+8K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+8K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+8K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+8K151146N-Force Fixation SystemInnovision, Inc.20151—
+8K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+8K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+8K150626Rush Medullary PinsZimmer, Inc.20150—
+8K132244N-Force Fixation SystemInnovision, Inc.20143—
+8K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+8K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K221172FOCUS Interbody SystemOc Medical Devices20220—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+9K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—