510(k) Report

Devices descending from K023555

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+8K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+8K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+8K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+8K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+8K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+8K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+8K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+8K172194Connector SystemOrthofix, Inc.2017162
+8K151216Everest Spinal SystemK2m, Inc.201511—
+9K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+9K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K260546Q Pedicle InstrumentsK2m, Inc.20260—
+9K252873Q Interbody InstrumentsK2m, Inc.20260—
+9K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+9K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+9K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K231658VEOS Spinal Fixation SystemSpineway20230—
+9K223273ASTRA Spine SystemSpinecraft, LLC20228—
+9K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+9K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+9K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+9K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+9K210549ARx Spinal SystemLife Spine, Inc.20211—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+9K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+9K190751Connector SystemOrthofix, Inc.20193—
+9K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+10K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+10K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+10K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+10K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+11K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+11K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K252322SIros-X SystemGenesys Spine20250—
+11K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+11K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+11K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+12K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—