510(k) Report

Devices descending from K010783

484 later devices reach 2.0/2.4 Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc20210—
+6K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+6K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+6K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+6K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc.20191—
+6K190230iFuse Implant System®SI-BONE, Inc.201957—
+6K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+6K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+7K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+7K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+7K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+7K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+8K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+11K252088Firebird SI Navigation SystemOrthofix US, LLC20251—