510(k) Report

Devices descending from K970635

72 later devices reach Titanium Spinal Rod System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462—
+1K020134Spiral Radius 90-D Rodding SystemUnited States Surgical, A Division of Tyco Healthc20020—
+1K980862Titanium Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc19984—
+1K980928Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation SystemSynthes Spine19980—
+1K974734Aurora Titanium Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc19984—
+1K974213Aurora Titanium Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc19984—
+2K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+2K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+2K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+2K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+2K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+2K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+2K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+2K983197Surgical Dynamics Rodding System (Previously Known as the Aurora Titanium Spinal Rod…United States Surgical, A Division of Tyco Healthc19983—
+3K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+3K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+3K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+3K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K992784Next Generation Rodding SystemUnited States Surgical, A Division of Tyco Healthc19992—
+4K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K080767Conquest Spinal SystemLife Spine200821—
+4K012273Spiral Radius 90-D SST SystemUnited States Surgical, A Division of Tyco Healthc20010—
+4K000009Spiral Radius Rodding SystemUnited States Surgical, A Division of Tyco Healthc20001—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K090320Conquest Spinal SystemLife Spine20092—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—