510(k) Report

Devices descending from K081952

255 later devices reach Synergy Spinal System (6.35 Polaris) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+10K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—