510(k) Report

Devices descending from K963172

722 later devices reach Synthes Sterile 4.5 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+7K173135VariAx 2 SystemStryker GmbH201713—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K171060OrthoButton ALRiverpoint Medical20178—
+7K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+8K253538TeKBrace Knotless AnchorTheramicro20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K253695LigaMendRiverpoint Medical, LLC20260—
+8K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+8K243988RootMend MRRRiverpoint Medical, LLC20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K240194ProCinch, QuadCinchRiverpoint Medical20240—
+8K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+8K233552IDEAL ZiploopRiverpoint Medical20230—
+8K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+8K230212OrthoButton ALRiverpoint Medical, 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—
+8K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+8K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+8K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K202399OrthoButton FLRiverpoint Medical20201—
+8K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+8K180500VariAx 2 SystemStryker GmbH201812—
+9K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+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—
+9K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+9K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+9K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+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—
+9K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+9K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+10K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+10K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+10K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+10K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+10K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+11K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+11K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—