510(k) Report

Devices descending from K053483

262 later devices reach Modification to Vertex Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K151216Everest Spinal SystemK2m, Inc.201511—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+8K210549ARx Spinal SystemLife Spine, Inc.20211—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+9K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+10K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+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—