510(k) Report

Devices descending from K111457

261 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K172194Connector SystemOrthofix, Inc.2017162
+6K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+6K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+6K190751Connector SystemOrthofix, Inc.20193—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+7K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+9K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—