510(k) Report

Devices descending from K963562

383 later devices reach Wright Plaster of Paris Pellets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K090387Kainos+Signus Medizintechnik GmbH20090—
+5K071004Osteocrete Bone Void FillerBone Solutions, Inc.20092—
+5K082002Progenix PlusMedtronic Sofamor Danek20080—
+5K082463ProgenixMedtronic Sofamor Danek20080—
+5K082073Actifuse Flow Bone Graft SubstituteApatech, Ltd.20084—
+5K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+5K073316Cerament Bone Void Filler, Model A0210Bonesupport AB20086—
+5K080736Actifuse Shape Bone Graft SubstituteApatech, Ltd.200879—
+6K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+6K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+6K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+6K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K233259XerosynXerothera, Inc.20240—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K240453ReBOSSISOrthorebirth Co., Ltd.202402
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K232668Cove Strip, OsteoCove StripSeaSpine Orthopedics Corporation20230—
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+6K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+6K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+6K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+6K201535Cerament Bone Void FillerBonesupport AB20203—
+6K201464Altapore MISBaxter Healthcare Corporation20201—
+6K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+6K182107CarriGen PFEtex Corporation20181—
+6K181306Actifuse FlowBaxter Healthcare Corporation20180—
+6K180853EP Granules™ BVFElute, Inc.20181—
+6K142828osteoSPAN MorpheusBiogennix20152—
+6K143547Vivorte Trabexus EBVivorte, Inc.201501
+6K142090RebossisOrthorebirth Co., Ltd.20140—
+6K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+6K102528N-Force Fixation SystemInnovision, Inc.20115—
+6K090871Cerament Ibone Void Filler High Contrast, Model a 0210-12Bonesupport AB20091—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253260ORIO-3D Cage SystemSpineCraft20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K250346BonVie+Elute, Inc.20250—
+7K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K193487Agilon StripBiogennix, LLC20200—
+7K193168Agilon MoldableBiogennix, LLC20200—
+7K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+7K151146N-Force Fixation SystemInnovision, Inc.20151—
+7K142776Flow-ScrewFlow-Fx, LLC20151—
+7K132244N-Force Fixation SystemInnovision, Inc.20143—
+7K121177Bond ApatiteAugma Biomaterials, Ltd.20130—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K173556Injection ScrewBiedermann Medtech, Inc.20180—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—