510(k) Report

Devices descending from K100089

797 later devices reach Synthes T-Pal Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+7K263049SABER-C SystemElevation Spine20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+7K243188Cylox® STSignus Medizintechnik GmbH20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K234150Lucent® XPSpinal Elements20240—
+7K240715Idys® C ZP 3DTiClariance20240—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+7K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230026SqualeImplanet, S.A.20230—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—