510(k) Report

Devices descending from K963192

581 later devices reach Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K230026SqualeImplanet, S.A.20230—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K221578Hexanium ACIFSpinevision, S.A.S.20224—
+9K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+9K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+9K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+9K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+10K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+10K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+10K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+10K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+10K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+10K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+11K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K250769Dakota LP SystemPrecision Spine, Inc.20250—
+11K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+11K232432E3D™-A Interbody SystemEvolution Spine20248—
+11K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+11K221172FOCUS Interbody SystemOc Medical Devices20220—
+11K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+11K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+11K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+12K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+12K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+12K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+12K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+12K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+12K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+12K240368E3D™-A Interbody SystemEvolution Spine20247—
+12K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+12K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+12K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+12K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+12K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+12K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+12K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+13K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+13K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+13K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+13K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+13K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+13K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+13K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+13K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+13K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+13K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+13K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+14K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+14K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+14K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+14K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+14K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—