510(k) Report

Devices descending from K040593

162 later devices reach Periarticular Locking Plates and Screws, 2358, 2359 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+4K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+4K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+4K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+4K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+4K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+4K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+4K082078Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna PlatesZimmer, Inc.200847
+5K262975Arthrex Beaming SystemArthrex, Inc.20260—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+5K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+5K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+5K180500VariAx 2 SystemStryker GmbH201812—
+5K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+5K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+5K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+5K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+5K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+6K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+6K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+6K191972ARIX Wrist SystemJeil Medical Corporation20190—
+6K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+7K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+8K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—