510(k) Report

Devices descending from K974017

53 later devices reach Timesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062348Timesh Self Drilling ScrewMedtronic Neurosurgery20063—
+1K023665Modification to Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20020—
+1K022033Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation…Bioplate, Inc.20021—
+1K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20027—
+1K020853Nuvasive MeshNuvasive, Inc.20020—
+1K994158Macrosorbos Protective SheetMacropore Biosurgery, Inc.200035—
+1K992106Modus System Self-Drilling ScrewsMedartis AG19990—
+2K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20102—
+2K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium…Bioplate, Inc.200801
+2K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20063—
+2K052041Collagen Bone Healing Protective SheetCollagen Matrix, Inc.20050—
+2K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemCeremed, Inc.20050—
+2K033918Ebi Lactosorb Graft Containment SystemEbi, L.P.20043—
+2K031961Inion Otps Biodegradable Mesh Plating SystemInion, Ltd.200421—
+2K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20030—
+2K023810Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc.20021—
+2K022139Hip Tool ImplantOrthopedic Sciences, Inc.20027—
+2K011715Macropore IB Resorbable PlugMacropore Biosurgery, Inc.20010—
+3K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY201317—
+3K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20120—
+3K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20111—
+3K073115OrthomeshSynthes (Usa)20081—
+3K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+3K063410Inion CPS/Otps FreedomplateInion, Ltd.20072—
+3K063709TS-Bone Hip ToolOrthopedic Sciences, Inc.20071—
+3K052538S-Bone Hip ToolOrthopedic Sciences, Inc.20050—
+3K051032Titanium-Hip ToolOrthopedic Sciences, Inc.20050—
+3K051181Custom-Hip ToolOrthopedic Sciences, Inc.20050—
+3K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc.20041—
+4K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+4K203105Inion CompressOn ScrewInion OY20210—
+4K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+4K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+4K180821TruMatch Graft Cage - Long BoneSynthes (Usa), LLC20180—
+4K160304OsteoBullet Compression ScrewPhalanx Innovations20168—
+4K121606Resorb-X GKLS-Martin L.P.20130—
+4K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+4K081588RE-Zorb Plating SystemAcute Innovations, LLC20081—
+4K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc.20070—
+4K063033Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc.20060—
+5K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+5K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+5K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+5K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+5K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+5K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+5K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+5K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+5K120163Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC20120—
+6K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+6K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+6K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+6K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—