510(k) Report

Devices descending from K951725

264 later devices reach Osteonics Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K131343Reform Pedicle Screw SystemSpinal USA201331—
+6K130279Reform Pedicle Screw SystemSpinal USA201331—
+6K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+9K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+10K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+10K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+11K230880CoreLink Navigation InstrumentsCorelink, LLC20230—