510(k) Report

Devices descending from K924138

581 later devices reach Osteomed M3 System (SBF System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+4K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+4K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+4K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+4K102528N-Force Fixation SystemInnovision, Inc.20115—
+4K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+4K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+4K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+4K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+4K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K202326BESPA Charcot SystemBespa Global, LLC20210—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+5K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+5K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+5K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+5K193368Smart Correction SystemWishbone Medical, Inc.202031
+5K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+5K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+5K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+5K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+5K193029Conquest FNSmith & Nephew, Inc.202010—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K190830TDM Screw SystemsTdm Co., Ltd.20191—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+5K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+5K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K181539OSSDSIGN CranioplugOssdsign AB20181—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+5K172785Conquest FNSmith & Nephew20178—
+5K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+5K162171S4 Screw System™Subchondral Solutions20173—
+5K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+5K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+5K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+5K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+5K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+5K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+5K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+5K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+5K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+5K152686Conquest FNSmith & Nephew201612—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—