510(k) Report

Devices descending from K020245

43 later devices reach Modification to Isobar Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+1K043001MX Polyaxial Pedicle ScrewScient'X200437—
+1K042964MX Monoaxial Pedicle ScrewScient'X200438—
+2K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K072685Ngarde SystemN Spine, Inc.200709
+2K062912Scient'x Spinal SystemScient'X200736—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K203452Nano FortiFix® SystemNanovis, LLC20200—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—