510(k) Report

Devices descending from K990118

250 later devices reach Isobar Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+7K182240PASS LP Spinal SystemMedicrea International SA20182—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K252322SIros-X SystemGenesys Spine20250—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+8K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+8K190376PASS LP Spinal SystemMedicrea International SA201915
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+9K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+9K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+10K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+10K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+10K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+11K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—